Category: Pharmaceutical

What to Expect During an FDA Inspection

Posted on by Brandon Miller

For companies operating in FDA-regulated industries—such as pharmaceuticals, medical devices, food manufacturing, and biotechnology—FDA inspections are an inevitable and crucial part of maintaining compliance. Understanding the inspection process and preparing adequately can make a significant difference in ensuring a smooth experience and maintaining compliance with FDA regulations.

 

Why Does the FDA Conduct Inspections?

The FDA (Food and Drug Administration) conducts inspections to ensure that companies manufacture high quality products and comply with federal regulations regarding the safety, efficacy, quality and labeling of their products. Inspections serve to verify that manufacturing facilities follow Good Manufacturing Practices (GMPs), adhere to safety guidelines, and produce products that meet established standards. The legal authority for inspections is outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 U.S.C. §374.

 

Types of FDA Inspections

FDA inspections can fall into several categories, including:

  1. Pre-Approval Inspections (PAI): Conducted before the FDA grants approval for a new product. These inspections verify the accuracy of the information submitted in regulatory applications (21 CFR Part 314.125 for drugs, 21 CFR Part 814.42 for medical devices).

  2. Routine Surveillance Inspections: Periodic inspections to ensure ongoing compliance with regulations. These can be announced or unannounced (21 CFR Part 820 for medical devices, 21 CFR Part 211 for pharmaceuticals).

  3. For-Cause Inspections: Triggered by a specific concern, such as a complaint, adverse event, or suspected regulatory violation (21 CFR Part 7.3(g) outlines recall classifications based on these inspections).

  4. Compliance Follow-Up Inspections: Conducted to verify corrective actions taken in response to previous inspection findings.

 

Sampling During Pharma Inspections

To help ensure that high-quality drugs are sold in the U.S., FDA maintains a comprehensive quality surveillance program. A critical function of this program is testing selected drugs in FDA laboratories. This includes testing active pharmaceutical ingredients (APIs). FDA laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP), an organization that publishes quality monographs for medicines including attributes such as:

  • Identity: is it the right drug as indicated on the label?
  • Assay: how much drug is there and is it consistent with the labeled amount?
  • Impurities: are impurities within established specifications?
  • Dissolution: does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?

FDA quality surveillance program includes multiple tools that complement sampling and testing. These tools include sampling assignment as a result of inspections, evaluation of post-market quality reports, signal detection, and data analysis.

 

What Happens During an FDA Inspection?

While each inspection may vary slightly depending on the industry and facility type, most follow a structured process:

  1. Notice of Inspection: The FDA may or may not provide advance notice of an inspection. When notified, companies should quickly organize relevant personnel and documentation (FDA Form 482 – Notice of Inspection).

  2. Opening Meeting: The FDA investigator(s) will present their credentials and explain the purpose and scope of the inspection.

  3. Facility Walkthrough: Inspectors tour the facility, observe operations, and assess compliance with regulatory requirements.

  4. Document and Record Review: The FDA will request to review various documents, such as standard operating procedures (SOPs), batch records, testing, employee training records, deviation reports, verify data integrity, ALCOA and (21 CFR Part 11 for electronic records and signatures).

  5. Interviews: Inspectors may interview employees at various levels to gauge their understanding of compliance requirements and daily operations.

  6. Observations and Notations: Any potential violations or concerns are noted, typically recorded on FDA Form 483 and issued at the close of an inspection.

  7. Closing Meeting: The inspector provides preliminary feedback and discusses any observations that may require corrective actions.

 

How to Prepare for an FDA Inspection

  1. Maintain a State of Readiness: Always operate as if an inspection could occur at any time.

  2. Train Employees: Ensure that staff members understand regulatory requirements and are prepared to answer questions confidently and accurately.

  3. Conduct Internal Audits: Regular self-inspections can help identify and address potential compliance gaps before an FDA inspection.

  4. Organize Documentation: Maintain well-organized, readily accessible records to streamline the document review process.

  5. Establish an Inspection Plan: Have a clear strategy in place, including designated personnel to guide inspectors, manage documentation requests, and address findings promptly.

 

Post-Inspection Actions

After an FDA inspection, the company may receive an FDA Form 483 if compliance issues were noted. Addressing these findings promptly through corrective and preventive actions (CAPAs) is crucial to demonstrating commitment to compliance. In some cases, the FDA may issue a Warning Letter (21 CFR Part 7.3) if significant violations are found, which requires a more formal response and resolution.

 

Conclusion

An FDA inspection is a critical event that can impact a company’s ability to operate and bring products to market. Proper preparation, adherence to regulatory standards, and a proactive compliance culture can help companies navigate inspections successfully. By staying informed and ready, businesses can not only pass inspections but also strengthen their overall compliance programs and ensure public safety. 

 

Are you prepared for an inspection at your facility? Regulatory Compliance Associates® (RCA) can help your team prepare for inspections, manage inspections or help remediate any adverse findings once the inspection is complete. From developing a training program that suits your professional needs, company goals, and preferred learning style. To working with your leadership to create a response strategy, we have you covered.

 

 

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. You may also email us at [email protected].

 

 

Changes in Drug Labeling & Transparency

Posted on by Brandon Miller

The FDA is cracking down on labeling for drug products that will require companies to reevaluate and make changes to new and existing products if they wish to stay in compliance. To ensure companies can continue production without slowdowns, it is important to understand what changes are being implemented and how they will affect your products.

 

Greater Transparency in NDA and ANDA Labeling

In April 2024, the FDA released a draft guidance aimed at improving transparency in drug labeling, particularly for New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs), which cover generic drugs. Generic drug labeling must contain information to show that the proposed labeling is the same as that for the Reference Listed Drug (RLD), with certain permissible differences. Under 21 CFR 314.50, an NDA must contain a list of all components used in the manufacture of the drug product.  However, historically, there have been several instances whereby the NDA did not disclose all of its ingredients in the labeling,   leading to complications in the regulatory approval process for generic versions. This lack of transparency created delays and regulatory hurdles for ANDAs that relied on accurate ingredient information from their RLD.

 

Moving forward, the FDA is advocating for clearer and more comprehensive ingredient disclosures on NDA and ANDA labels. For example, labeling for non-oral drug products may need to contain the names of all inactive ingredients with limited exceptions.  This shift is intended to eliminate unnecessary review delays and improve the efficiency of ANDA approvals. While the exact compliance strategies remain unclear, the draft guidance from April 2024 is expected to shape regulatory expectations well into 2025 and beyond once the guidance becomes finalized.

 

This change marks a significant step toward improving the drug approval process. Greater transparency in ingredient listings will not only help generic drug manufacturers but also ensure that healthcare providers and consumers have access to complete information about their medications. The push for increased clarity aligns with broader FDA efforts to enhance drug safety and efficacy.

 

New Labeling Rules for OTC Drugs

Another critical update in drug labeling comes with the final rule for non-prescription (over-the-counter, or OTC) drugs under the Additional Condition of Nonprescription Use (ACNU) framework. Published in December 2024, this rule introduces new labeling requirements for certain OTC products to enhance consumer safety and regulatory oversight.

 

Under the ACNU framework, some OTC drugs will require additional steps before consumers can access them. These measures may include visiting the manufacturer’s website or completing a brief manufacture’s to determine whether the product is suitable for individual use. This regulatory approach seeks to strike a balance between expanding consumer access to safe and effective nonprescription medications while ensuring that people use them appropriately.

 

The implementation of this rule could significantly impact both consumers and pharmaceutical companies. On one hand, it enhances safety measures by ensuring that individuals receive proper guidance before using certain OTC drugs. On the other hand, companies will need to update their packaging, labeling and digital platforms to comply with the new requirements. Consumers may also need to adapt to these changes by engaging with manufacturers’ resources before purchasing certain OTC products. The final rule is intended to increase options for consumer access to appropriate, safe, and effective drug products, which could improve public health.

 

What to Expect

These labeling and transparency initiatives will likely play a major role in shaping the pharmaceutical landscape in the future. The FDA’s push for improved ingredient disclosure in NDAs and ANDAs is expected to streamline generic drug approvals and foster greater trust in drug labeling. Meanwhile, the ACNU framework will redefine how consumers interact with select OTC medications, prioritizing informed decision-making and responsible use.

 

Stakeholders, including drug manufacturers, healthcare providers, and consumers, should stay informed about these evolving regulations to ensure compliance and safe medication practices. As the FDA continues refining its policies, further clarifications and potential updates may emerge, reinforcing the agency’s commitment to transparency and consumer safety in the pharmaceutical industry.

 

Preparing for These Changes

For companies looking to stay ahead of these regulatory updates and maintain seamless approvals and production, it is essential to assess current processes and identify gaps in compliance with the new FDA guidelines. Engaging with third-party auditors with relevant expertise can help pinpoint deficiencies and develop a robust implementation strategy, ensuring compliance from the outset.

 

At RCA, we leverage our extensive network of industry experts, including former FDA consultants and leading auditors, to provide comprehensive support. Whether identifying and addressing compliance gaps or designing entirely new processes for emerging products, our team ensures a seamless transition to meet evolving regulatory expectations. Let us help you identify any gaps and help you form a clear strategy that will keep your drug labels in compliance today.

 

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. You may also email us at [email protected].

 

Leveraging Outsourced Staff

Posted on by Brandon Miller

 

In this soundbite from RCA Radio, Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), provides examples of how different size companies leverage the stage of business they’re in to accelerate development with outsourced staff.

 

Start ups vs Large Companies

 

Using Staff augmentation to bring in SMEs gives companies the ability to scale up and scale down quickly without taking away people from other projects.

Start-ups are typically not ready to bring on a full-time employee. In cases like these, we can bring in a subject matter expert (SME) that can help work through any regulatory, compliance, or quality problem and assist on an as-needed base.

 

Larger companies typically need help when they are performing a project such as adding a new manufacturing line into a facility. They don’t do this all of the time and only need the extra resources for this particular project. In cases like these, we will put together a team with the right skillsets that can complete the particular project. Once completed, RCA perform a hand-off with the client, and our team steps away from the project. 

 

Listen to the full episode “Outsourcing and Staff Augmentation” now!

 

All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA has consultants that develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.

 

Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. These companies turn to outsourcing to manage operations and tactical skills, and also help adopt best practices.

 

Successful execution comes through project monitoring, issue resolution, and risk management of the process through clear leadership. RCA’s team of experienced project management professionals organize and manage resources to ensure that projects are completed successfully, on time, and within budget.

 

RCA Outsourcing Services

 

Project Management

outsourced staffTo be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently.

 

Our outsourced staff capabilities for project management capabilities include:

 

  • On-site Project Leadership or Project Management Support
  • Design and Implementation of a Project Management Office
  • FDA Workshops
  • Project Assessment, Remediation, and Follow-up
  • Advanced Schedule Optimization and Management
  • Development and Implementation of Compliant Methods
    • Risk Management
    • Issues Resolution and Decision Tracking
    • Change Management
    • Performance Measurement and Tracking
  • Tool Selection for Program Portfolio and Resource Management

 

Staff Augmentation

Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add experienced professionals to your staff for a short- or long-term project through our medical device staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:

 

  • Quality Assurance
  • Regulatory Affairs
  • Validation
  • Operations
  • Product Development

 

Consulting Support

Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.

 

Advantages of Outsourcing

 

When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. RCA’s quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution, and implement that solution for the utmost success in your project’s completion.

 

Our goal is to help you get your projects to completion on time and on budget — all while outsourced staff keeps superior quality at the forefront of your every task. And with a team of more than 500 pharmaceutical consultants and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.

 

Strategic Outsourcing

 

Medical device manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for outsourced staff and strategic outsourcing services.

 

 

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. You may also email us at [email protected].

 

 

Impact of QMS on Quality Maturity

Posted on by Brandon Miller

In an interview with Pharmaceutical Technology®, Susan Schniepp, distinguished fellow, Regulatory Compliance Associates®, and co-chair of board of directors, Parenteral Drug Association, expands on the importance of maintaining a robust quality management system (QMS) in bio/pharmaceutical manufacturing. 

 

For advanced therapy medicinal products (ATMPs) in particular, Schniepp emphasizes how fast-moving this sector is. “The regulations don’t keep up with the ATMPs. That technology, and their way of thinking, is turning over quicker than the regulatory standards,” she says.

 

Follow the link to watch the free video here

 

“The changes in the regulations that are going to come are going to be around quality culture and maintaining a robust quality management system,” she adds. Ensuring documentation and keeping equipment calibrated are important practices to apply to these new fast-moving ATMPs, she states. Schniepp does not necessarily expect to see many changes in the regulations around ATMP development and manufacturing but thinks that there will likely be more guidance documents issued in the future, with one of FDA’s focuses being its quality management maturity model.

 

“There are some regulations out there that call out quality culture. In particular, the World Health Organization has one on data integrity. It has a definition and standard[s] on what quality culture is,” Schniepp says. She points out that a new aspect of her presentation at INTERPHEX this year is its interactive component, in which she sets up a scenario involving an internal audit where an incident occurs. She gives the audience three potential responses to discuss, but rather than simply asking them which response do they pick or which response is correct, she instead asks what does the chosen response say about that person or that company’s QMS and the maturity of that system?

 

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. 

Crisis Management Playbook

Posted on by Brandon Miller

crisis management playbookDeveloping a crisis management playbook designed for the challenges of the pharmaceutical industry sector is vital to ensuring long term business continuity. Below are a few critical risk management elements you should consider for your team during crisis handling & developing a crisis management playbook.

 

Risk Management

 

Being able to identify factors that impacted product safety or regulatory compliance is one of the most important elements during the risk assessment phase. During RCA’s risk management services process, operational risk management is one of the first remediation steps to consider.

 

Identify Risk

 

Being able to identify the product hazards that caused the crisis is critical to understand scenario planning. Conduct due diligence to ensure that your product design outputs include no risks that are unnecessary to the consumer. Hazards that do include one or more risk factors must be analyzed why the patient benefit exceeds the financial risk.

 

Measure Risk

 

During scenario planning, identify the critical elements to measure your team and results by via a risk management framework. A risk profile for each product in question can support evaluating, reporting and monitoring adverse events. Systemic risk should be analyzed for product risk profiles with longer term, reoccurring events or specific pharmacovigilance indicators identified as proactive crisis control.

 

Mitigate Risk

 

Being able to work clearly and concisely with your regulatory agency is critical for the due diligence solutions presented for review. Examining all hazards that have been identified during the risk mitigation phase is essential to success during the risk management process. Consider any of the threats that are regarded as acceptable with known risks and document unusual activity in your risk management plan.

 

Crisis Management Communications

 

An initial step recommended by RCA’s medical device consulting team is to identify and evaluate the regulatory compliance dangers and situations. For example, assessing the vulnerability of medical device cybersecurity must consider internal and external threat modeling. Any type of cyber breach that might impact your operations team, business reputation, or stakeholder relationships should have a detailed communication strategy.

 

Crisis Communication Plans

 

A veteran RCA medical device consultant suggests developing a universal shared space where team members can bookmark & access the crisis comms document. A communication strategy would then be shared with communication partners engaged in the public relations and crisis management campaign.

 

Risk Management Communications

 

Inside a successful crisis communication team, everyone knows their role and responsibilities. RCA’s regulatory consulting Experts often designate a process leader who clearly understands the team stakeholders and functions they represent. Refine your approval process so that messaging not only meets external approved communications from these stakeholders, but also legal concerns.

 

Crisis Control

 

A detailed risk management communication plan helps specify different examples for sharing risk messaging to either internal audiences or external stakeholders. Design your communication plan templates so that information is easy to understand for multiple audiences. Different types of tactics to be considered for templates (e.g. press release, social media) to confirm the messaging reliability of the crisis communication strategy.

 

 

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. You may also email us at [email protected].

Outsourcing Post Market Surveillance and Support

Posted on by Brandon Miller

One of the most crucial parts of running a business in the pharmaceutical or medical device industry is meeting the standards that will ensure your customers receive the highest-quality service. That’s why many businesses today choose to outsource certain functions of their post market surveillance activities.

Let us help you Outsource your Post Market Surveillance Activities. Contact Us Now →

Outsourcing is a business strategy that only began to surface in the 1980s and 1990s. Since then, it has become a powerful value proposition for industries everywhere. In the 2000s, businesses within the life sciences industry started implementing the practice. Now, the outsourcing of external resources for compliance needs is a common strategy for companies looking to expand their reach and climb the industry ladder.

 

Why Are Certain Functions Targeted for Outsourcing?

Companies may choose to outsource any number of activities to improve business operations, but there are a few specific types of functions that leaders tend to target for outsourcing. For example, companies often outsource lower risk activities that include higher volume but lower-complexity tasks.

 

The reason for this is that there are many expert consultants needed for complicated specialties that businesses are responsible for. However, when leadership removes the tedious or time-consuming tasks, such as data management, they may increase the team’s ability to focus on the larger picture or invest in business ventures.

 

Outsourcing low-risk tasks lifts a significant burden from the shoulders of leaders and employees while allowing them to focus on the creative, strategic and higher-risk parts of the business instead.

 

Why Outsource Post Market Surveillance Needs?

The reason so many businesses choose to outsource rather than use internal resources is the challenge of the recruiting process. Companies often find that understanding regulations, compliance, hearing the Voice of the Customer and managing regulators is an important core competency / knowledge that balances other internal functions and decision making. Thanks to ever-changing standards and laws in the medical device and pharmaceutical industries, very few companies have the in-house resources to keep these standards up-to-date.

 

Managing post market surveillance activities may be outside the realm of your team’s skill set and understanding, but outsourcing allows you to work with experts in the field. While compliance issues can hold your company back, having an experienced partner at your side ensures that all of your compliance needs will be in order.

 

Some of the long-term benefits of outsourcing post market surveillance activities include:

  • High-efficiency value proposition: With the help of an healthcare consulting firm, you can more quickly and effectively serve your customers. Over a long-term basis, this will help you both retain customers and attract new ones.
  • Lower functional costs: Reducing operational costs so you can increase profits and grow as a business is one of your main goals. Thanks to the benefit of a more efficient work environment, you will save capital for opportunities like mergers and acquisitions.
  • Refocus talent and skill: Free up your high cost internal resources to allow them to focus on critical work and decisions which you can then leverage for the benefit of your business by outsourcing low-risk tasks. Refocus your most valuable members and resources on their greatest strengths while leaving the rest to external experts.

 

Outsourcing your post market surveillance activities is an area that continues to grow worldwide. With the help of a third party, you can keep everyone in your business assigned to the tasks that allow them to best use their core competencies and create a more productive work environment.

 

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.