Tag: eu gmp consultant

regulatory compliance

Regulatory Compliance Associates® will be exhibiting at CPhI North America 2023 in Philadelphia with Sterigenics and Nelson Labs. Stop by booths #934 and #932 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

 

About CPhI NA

CPhI organizes the most important and widespread series of global pharmaceutical events. Our gatherings are both renowned and revered—but it didn’t start in North America. With massive events throughout Asia, South America, Europe, and beyond…more than 500,000 powerful and respected pharma players from every aspect of the supply chain understand that CPhI is where they connect to learn, grow, and conduct business. With a 30-year tradition and an infrastructure fine-tuned to unite buyers, sellers, and industry trailblazers, we expanded this iconic worldwide events portfolio into the most progressive mega market on earth.

 

Client Solutions

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

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA®, we offer the experience and resources necessary to guide you in quality compliance.

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

 

Quality Assurance

Regulatory Compliance Associates® Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts 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.

  • 21 CFR 210
  • 21 CFR 211
  • Data Integrity
  • Computerized System Validation
  • Manufacturing Support
  • Facility Support

 

Remediation 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

About RCA

regulatory complianceRegulatory Compliance Associates® (RCA) provides regulatory compliance 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. Our life science consultants 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
  • 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®.

regulatory complianceSotera 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.

 

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. 

 

 

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®

Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

Life Science consultants

 

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. Our life science consultants 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
  • 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 healthSotera 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.

 

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. 

 

 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue
Privacy Policy