Client Size:

Global Medium Sized Company

Industry:

Pharmaceutical / Clinical Trials Supply

Project Timeline:

90 days + ad-hoc hours after submission

Business Challenge:

A Regulatory Compliance Associates client needed strategy and supprt with Pharma Licensing and Packaging & Labeling for a new greenfield facility.

 

Client Challenge

• An existing pharmaceutical client specializing in clinical trials supply was looking to launch a new packaging facility. The manufacturing operations team needed support with development plans and regulatory compliance.
  • Requested Executive level consultant to validate entire packaging facility for FDA & EU compliance. Included in the validation plan were many different facets of production:
    • Pharmaceutical packaging
    • Labelling in pharmacy
    • Pharmaceutical bottle
    • Packaging for tablets

RCA Approach

• Scope of work included two staff augmentation resources to begin the project. 
  • The first resource was a Quality Specialist consultant with experience in Risk Management & Quality Systems.
    • The Quality Specialist became a valued liaison while operating across departments inside the organization
      • Risk management tools were implemented in the following departments
        • Sterilization
        • Design Control
        • Validation
        • IT
        • Training employees.
  • The second resource was a Quality Subject Matter Expert with executive experience.
    • This type of high-level resource has the broadest based expertise able to effectively drive strategic discussions with corporate executives and business unit functional leaders.
      • All types of medicine packaging
        • Pharmaceutical packaging technology
          • Pharmaceutical filling
          • Pharmaceutical packaging solutions
        • Drug packaging types
          • Pharmaceutical primary packaging
          • Pharmaceutical secondary packaging
          • Pharmaceutical cold chain packaging
          • Plastic pharmaceutical packaging
        • Pharmaceutical labeling process
          • Pharma label
          • Pharma containers
          • Drug carton
          • Sustainable pharmaceutical packaging
        • Pharmaceutical packaging machinery
          • Blister packaging pharmacy
          • Unit dose packaging pharmacy

They also provide technical input and guidance from the perspective of many disciplines. After the implementation done by our Quality Specialist, this SME did the final validation of the plan and worked with the client on a “as needed” bases helping with any regulatory compliance issues.

Results

• RCA’s Quality Specialist worked collaboratively with the clients’ teams to valitate all training and SOP development. Enhancements for the new packaging facility included.
  • Design Control team was trained extensively on risk management in packaging.
  • Technology team improved their manufacturing automation through functionality that recognized the difference between “Printed Text Error” and “Packaging Component” deviations.
    • This helped isolate the number of errors to a specific step in the package leaflet process. 
• Assisted in identifying any gaps and/or opportunities with the firm’s plan.
  • Supported with any FDA authority enquiries and other global scenarios impacting the firm’s US Operations.
  • Implemented the secondary packaging and labelling protocols to match current licensing and marketing approval.

Conclusion

• At the end of this project, the Quality Subject Matter Expert with executive experience delivered a comprehensive readiness check for the facility.
  • All the regulatory requirements
  • Inspection readiness recommendatons
  • Process and production line validations
  • SOP documentation and training qualifications
• The client was approved by both global regulatory bodies to successfully begin development of their new packaging facility. 

 

About Regulatory Compliance Associates

Regulatory Compliance Associates (RCA) provides life science consultants & consulting services to the following industries for resolution of compliance and regulatory challenges:

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

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 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’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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, 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^®’s 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 life science consultants 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 Part 11
• Data Integrity
• 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.

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

 

RCA’s Medical Device Consulting Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA^®‘s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 life science consultants — including former FDA officials and other 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. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

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 we 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, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates^® ‘s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We 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 are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

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

 

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^® Inc. can help.

Our network of over 500 FDA, Health Canada & MHRA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

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

 

Quality Assurance

Regulatory Compliance Associates^®‘s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our life science 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.

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 RCA^®, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry Experts are fully equipped to handle your unique QA needs.

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

 

Remediation Support

Regulatory Compliance Associates^® is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

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 unique expertise and experience that makes partnering with RCA^® Inc. 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^® life science consultants can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 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
• Product Complaints
• Medical Information

 

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