Tag: Supply Chain

Postmarket Surveillance: Leveraging Outsourcing

Posted on by Brandon Miller

Companies within the life sciences industry have been increasing their use of third parties to manage postmarket surveillance activities in recent years. If you are thinking about outsourcing some of your company’s more time-consuming tasks, it’s important to keep in mind that there are both advantages and disadvantages to this method.

 

Interested in Outsourcing your Postmarket Surveillance activities? Contact RCA Now →

 

Below, we will discuss some of the pros and cons of outsourcing so that you have the knowledge to make the right choice for your business.

 

Pros

 

  • Reduced costs: Outsourcing your post market surveillance activities will improve upon your overall business functions, thereby reducing operating costs and increasing profits. You can use those savings to foster growth for your company.
  • Leveraging resources: While cost is one of the main benefits to outsourcing quality assurance, the advantages offer so much more. For example, you can use the time and effort you save on post market surveillance to leverage your talent and resources on other high-value tasks. By delegating less complex work to a team of compliance experts, you can make the most of your valuable employees with riskier responsibilities.
  • Taking advantage of core competencies: What are your team members’ strengths in relation to your customers’ needs? This question will weigh heavily in your decision to outsource, especially if your internal resources lack the qualifications necessary to handle regulatory affairs. Outsourcing allows you to focus on your own core competencies while using a third party’s core competencies to increase productivity.
  • Improved speed and efficiency: If a task falls outside your core competency, it will take longer to complete it, with a greater risk for error. However, outsourcing to an expert speeds up your processes and helps create a more efficient work process for all parties involved.

 

Cons

 

  • Less direct control: When you outsource business processes, you release direct control you might otherwise have over those processes. It’s important to keep this in mind if you know that a mistake or failure of a task could have serious implications on the business.
  • Pressure on supplier management control: Outsourcing places pressure on your supplier management controls, which could result in losses for your company if poorly handled. As a result, you will need to establish a co-governance plan that allows you to retain some control.
  • Quality of the process: Potential negative impact on quality of the process outcome or services and its impact on profitability and customer satisfaction.

 

About RCA’s Pharmaceutical Consulting Services

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of outsourcing quality assurance. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the outsourcing quality assurance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our outsourcing quality assurance team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

postmarket surveillanceRegulatory Compliance Associates® (RCA) provides outsourced quality assurance services to the following industries for the resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

GMP Inspection

Posted on by Brandon Miller

GMP inspectionHealth Canada, Therapeutic Goods Administration (TGA), and Medicines & Healthcare Regulatory Agency (MHRA) recently launched an innovative, new pilot focused on Good Manufacturing Practices (GMP). The Single Inspection Program is designed to help rationalize the number of inspections needed to increase efficiency during the regulatory process.

 

A primary objective is to maintain regulatory standards by eliminating redundancies and providing a more “global approach to GMP inspections of third-country manufacturers”. Additionally, the program design is intended to increase existing collaborative GMP arrangements to allow for:

 

  • More efficient inspection reliance processes
  • Reduced regulatory burden on healthcare industry
  • Enhanced regulatory oversight of global supply chains

 

Regulatory Authorities

 

In a proactive step toward harmonization, the three regulatory bodies will begin accepting a single inspection for a Canadian, Australian and British regulatory application (based on the drug establishment license, or DEL). The long-term strategy includes leveraging the inspection assets of each regulatory authority to collectively collaborate when additional data is available.

 

Additionally, by maximizing the global regulatory reach of multiple agencies, the pharmaceutical industry will benefit from fewer inspections needed at the same site or manufacturing facility. This should increase both the speed of the regulatory process and patient access to medical products. Both are a win-win for the life science industry as the regulatory process becomes more streamlined than previously experienced.

 

GMP Practices

 

All three regulatory bodies are members of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S is an international, non-binding cooperative between Regulatory Authorities in the field of Good Manufacturing Practice (GMP). Additionally, PIC/S membership is focused on companies that develop medicinal products for human or veterinary use, and over 50 countries from around the world currently participate. 

 

Finally, the mission of the current membership is to lead the “development, implementation, and maintenance of harmonized GMP standards and quality systems”. A more efficient inspection process will allow drug manufacturers to reduce any type of disruption to operations that multiple audits may induce. 

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.

 

Pharmaceutical Supply Chain

Posted on by Brandon Miller

During times of crisis — such as the global pandemic — keeping supply chains moving becomes even more important. Issues with supply chains can lead to critical shortages of items like medications, which people need to remain healthy and combat the situation at hand. Unfortunately, the COVID-19 outbreak has caused early disruptions to the pharmaceutical supply chain as companies adjust their policies.

 

The long-term health of manufacturing will depend on the adoption of new approaches and care in pursuing solutions that may be impacted by future legislation or restrictions related to each industry. Here are some ways your company can do its part in maintaining the pharmaceutical supply chain during and after the coronavirus outbreak.

 

Having trouble with your Supply Chains?  Contact RCA Now →

 

Open up Lines of Communication

 

Communication at all levels between clients and suppliers becomes essential during difficult times. Transparency and early warnings on both sides can help you avoid instances of confusion and blame. When you’re on the same page, even if you do not hear the answers you want to hear, you can figure out how to deal with the situation productively. Be up front about delays or issues you run into along the way so that your clients understand the situation.

 

Review Your Quality Risk Management Plan

 

The global pandemic has required many changes to the way we work. For instance, you may be dealing with issues such as delayed supplies on your end, with overseas shipments arriving long after they’re expected. You’ll need to review your quality risk management plan to account for such unexpected dilemmas.

 

Conduct a thorough analysis of all the ways your own pharmaceutical supply chain may be impacted. For instance, other countries may have tightened their export requirements, which will make it harder to access the material you need. Countries may have increased security, which means more detailed inspections of exports and potentially longer delays. Consider other ways materials might be affected as they travel to your plant too, and make proactive changes to address these issues.

supply chain

 

Adjust Production Schedules

 

The production schedule you used before the COVID-19 pandemic may no longer make sense. You’ll need to adjust your schedules based on when you receive the materials you need and any new timelines instituted with your clients due to the outbreak. Make it clear to your workers why you are initiating the changes. You need buy-in from top to bottom on changes to ensure as few hiccups in the transition as possible.

 

Monitor Your Supplies

 

Everything is moving more slowly right now, including the movement of supplies. The quicker you can adjust to these changes, the less they will interrupt your production process. Know where your supplies are and track their arrival while anticipating any possible disruptions. Some facilities abroad are not ready to return to production. Other countries have shut down borders. Educate yourself on the circumstances that could impact your supplies.

 

Foresight and planning ahead can help you focus on the things you can control during this new and sometimes challenging time. Continuing your incorporation of crucial resources into the market is critical. If you need assistance with ways to maintain your supply chain, contact Regulatory Compliance Associates® Inc. for more information.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

FDA Medical Device Guidance

Posted on by Brandon Miller

The FDA Center for Devices and Radiological Health (CDRH) recently published new guidance for medical device priorities in 2023. The FDA CDRH guidance looks to evolve away from the COVID-19 pandemic and transition toward digital health, medical device software and regulated software as a medical device (SaMD).

 

Cybersecurity for Medical Devices

 

Among topics the FDA guidance considers “A-List” priorities is cybersecurity for medical devices. Two initial priorities of the FDA guidance will include a deeper study of quality system (QMS) considerations and premarket submission (PMA) content.

 

Additional FDA software guidance was published earlier this year (September 2022) that described how software functions meet the definition of a medical device and risks to the public. The change industry should keep an eye on is FDA product specific guidance that applies to regulating software development that impacts risk to patient safety.

 

Quality Management System

 

Quality management system regulation currently falls under 21 CFR 820, so it will be interesting to see how new updates are developed based on discussion with industry. Every medical device manufacturer is required to have a compliant QMS system that includes the necessary QMS documentation for regulatory approval.

 

As digital healthcare integrates the physician-patient relationship, FDA continues to scrutinize device software functions and healthcare mobile apps. Lastly, these insights may provide additfeedback on software functions not subject to FDA regulatory requirements relevant to a QMS audit.

 

Remanufacturing Medical Devices

 

FDA is taking a deeper look at reusable medical devices and how preventive maintenance increases the life of a medical device. Currently, there are separate regulations for both industry manufacturers and 3rd party service companies. FDA will look to clarify the differences between “servicing” and “remanufacturing”, and the impact on medical device safety for either. This will likely impact the regulatory responsibilities of companies who perform these activities for health care providers.

 

Premarket Authorization (PMA)

 

Software as a medical device continues to grow across the health care industry. Updated premarket authorization guidance will focus on software devices with consideration to how the software is delivered to the end user. This can include factory-installed healthcare software or platforms installed by a third-party vendor.

 

Equally important, new information is anticipated for different types of firmware and software-based control of medical devices. Industry employees should also anticipate greater clarity for stand-alone software applications and general purpose computers. Leadership at FDA has included subtle hints that accessories to medical devices that include software may also be included in future FDA guidance for industry.

 

COVID-19 Emergency Use Authorization (EUA)

 

There has been discussion around the 180-day timeline proposed for notice of ending a medical device EUA due to COVID-19. Final guidance should be available in 2023 that provides more detail about on the appropriate transition period. FDA is considering industry recommendations that avoid disruptions to product shortage and supply chain.

 

Further, consideration is also being given to medical device manufacturer and healthcare providers to adjust from policies adopted during the public health emergency (PHE). For example, an EUA issued under section 564 of the FD&C Act will remain in effect. Primary changes will be based on if FDA chooses to revoke the EUA because the criteria for issuance is no longer met. 

 

Voluntary Improvement Program

 

FDA and the Medical Device Innovation Consortium (MDIC) continue to advance their pilot program launched in 2018. Select medical device manufacturing sites were chosen to review key business processes using a series of integrated best practices. The Capability Maturity Model Integration (CMMI) Institute certified select team to conduct and review quality system maturity of these sites.

 

Additionally, 2023 will likely bring even more data surrounding the MDIC program. This could include public info for industry about continuous improvement through quarterly check-in progress with participating medical device companies. The program is designed to report industry baseline metrics after the check-in and monitor operational excellence.

 

Breakthrough Devices Program

 

New information from FDA will arrive in 2023 for updates to the Breakthrough Devices Program. Early updates suggest the guidance will clarify how the program may be more applicable to certain devices than others. FDA breakthrough designation often benefits populations that are more likely to be impacted by health care disparities. New clarity may include breakthrough therapy designations and how medical device companies can educatee sponsors to submit for proposed indications of use. 

 

Finally, an important facet of the breakthrough devices program is the type of evidence needed for FDA approval. Clarity should help to determine whether a device is reasonably expected to increase the treatment or diagnosis efficacy. Moreover, early indications suggest that the intended use of the device, technology and features, and the available standard of care alternatives will all play a role.

 

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

medical device consultingRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Audit & Internal Control

Posted on by Brandon Miller

While audits are not being conducted in the same way they were before the global pandemic, they continue to take place. New procedures adopted to deal with the coronavirus outbreak may have the unintended consequence of creating compliance gaps. An audit will identify these gaps so that you can address the issue. Understanding how the audit process has changed and what you may need to do differently can help your company navigate more smoothly.

 

Internal Control: What Processes Will Change?

 

Advance planning and proactive execution of your plan will put your company on track to conduct and complete internal, supplier and due diligence audits. Many of the processes you’re used to will change. Here’s how to prepare.

 

Auditboard: Did you Complete Advance Work?

 

You can complete some tasks off-site and in advance, such as reviewing standard operating procedures and the auditboard. You can also conduct teleconferences in advance to discuss any questions that will come up, or email ahead of time to find answers.

 

Certified Internal Auditor: Did you Hire an Expert?

 

Apply social distancing to the audit process by using video to substitute for certified internal auditor in-person visits when you can. Live streaming allows the certified internal auditor to view a facility instead of going there and possibly introducing new germs into the environment. Whenever possible, avoid walking around your employees during this process.

 

Acknowledge that the situation is not ideal. Giving auditors firsthand experience in your plant is preferable, but for the time being, it’s not always practical. Discuss what will happen to the tapes after the audit is over too so that your management team stays on the same page regarding disposal or preservation.

 

Audit Office: Are you Prepared for Virtual Interviews?

 

Interviews play a critical role in the audit process, and they will continue to serve auditors’ interests. Migrate audit office interviews to a virtual platform, and use teleconferencing apps to schedule and conduct them.

 

Audit Report: Increase the Transparency

 

The world has changed in a very short time due to the pandemic. This has led companies like yours to adopt new policies to curb the potential spread of COVID-19 or other infectious conditions. An audit offers the perfect opportunity to reexamine the audit report and increase the transparency of results. More departments and individuals should receive leeway to report deviations they see in the production process. Clarify your expectations for reporting in all aspects of production, including:

 

  • Manufacturing operations
  • Quality control
  • Compliance assurance
  • Supplier quality

 

Internal Control: Are you Building Trust?

 

Building trust with employees within a new internal control structure will put you on the path toward solving any audit issues uncovered. The goal of giving the public a reliable supply of needed products will become an achievable aim as a result. Continuing the audit process and running it smoothly is critical to public health. Companies must continue to uphold the supply chain for essential resources so that people receive the provisions they need.

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

auditRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Pharmaceutical Supply Chain Consulting

Posted on by Brandon Miller

About Regulatory Compliance Associaties

 

Regulatory Compliance Associates (RCA® ) provides pharmaceutical supply chain consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, supply chain, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

RCA Pharmaceutical Supply Chain Consulting Services

 

The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:

 

Assessments 

 

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

 

Our range of compliance consulting services includes:

 

  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.

 

Audits 

 

Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:

 

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

 

Regulatory Agency Response 

 

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

 

  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans

 

Preparation, Training, and Inspection Readiness 

 

Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:

 

  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations

 

Data Integrity

 

Training:

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting:

 

  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

cGMP Consulting

 

Maintaining data integrity is an important part of ensuring the manufacturing quality of your pharmaceutical. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

 

In a time when compromised data has become a common concern among businesses in the life science field, it’s become more critical than ever to maintain healthy practices concerning data storage and release. Medical device companies of all sizes and types need to trust their data’s integrity, which is why thousands of businesses have turned to Regulatory Compliance Associates® for GMP quality compliance services.

 

With a team of more than 500 industry experts and seasoned veterans of the FDA, we know what it takes to adhere to the standards of global regulatory bodies. We offer the expertise needed to help your business stay within cGMP and preserve your data’s integrity. Our array of training and consulting services will ensure that your customers’ trust in your brand is well-placed.

 

GMP Quality Compliance Services

 

Training

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting

 

  • cGMP Consulting
  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with the execution of Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of your medical device—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

Manufacturing Processes

 

Our comprehensive evaluations will identify GMP pharmaceutical practices that consistently yield a sustainable return on investment. We will help you identify opportunities for:

 

  • Reducing Set-Up Times
  • Increasing Throughput
  • Reducing Inventory Levels
  • Lab Efficiency Improvements
  • Scrap and Waste Reduction
  • Cycle Time Compression
  • Capacity Creation
  • Process Automation
  • Cost Reduction

 

Manufacturing Optimization

 

Regulatory Compliance Associates provides the following manufacturing optimization services:

 

  • Program Analysis
  • Process Optimization through Engineering Studies
  • Statistical Process Control
  • Lean Innovative Product / Process Solutions
  • Value Stream Mapping
  • Kaizen Events
  • Design for Six Sigma
  • Inventive Problem Solving

 

Automated Industrial Services

 

Regulatory Compliance Associates  provides manufacturing automation consultants with deep industry experience including:

 

  • Validation Master Plan
  • Development of Validation Documentation
  • Validation Services
  • Risk Assessments

 

Factory Automation

 

Regulatory Compliance Associates helps clients develop innovative factory automation via design strategy and hands-on validation support. We ensure that updating manufacturing facilities will continue to meet all regulatory and client requirements, without an adverse impact on the finished product.

 

  • HVAC Systems and Associated Controllers
  • Medical Gas Systems
  • Plant and Pure Steam Systems
  • Water Systems including USP, RO / DI, and WFI
  • Compressed Air Systems
  • Controlled Environments

 

Pharmaceutical Contract Manufacturing

 

When you choose Regulatory Compliance Associates as your pharmaceutical manufacturing consultant, you’ll have the support of validating every contract manufacturer. RCA provides the combined skills and knowledge of more than 500 pharmaceutical and medical device experts who are experienced at working on the front lines of regulatory requirements. RCA clients benefit as these solutions move suppliers toward a culture of quality, from startups to Fortune 100 international enterprises.

 

Quality Management System

 

To create a positive change in the lives of patients counting on the availability of your product, you need to recognize the regulatory pathways of drug manufacturing companies that are ahead of you. Further, this includes the evolving technical development of your quality management system. When you work with us, you get a team that tailors its services to the comprehensive needs of your company. And that’s how you can be assured you’ll always receive the support you need to implement corrective action wherever it may be needed.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.