case study

Regulatory Due Diligence

Wanting to purchase a medical enterprise, a private equity firm contacted RCA to perform a technical due diligence analysis of a target company within an extremely tight timeline.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Regulatory Due Diligence

Background

due diligence processWanting to purchase a medical enterprise, a private equity firm contacted Regulatory Compliance Associates® Inc. to perform a regulatory due diligence analysis of a target company within an extremely tight time-line.

The due diligence process included multiple operations in North America, Europe, and East Asia. The nature of the target enterprise presented potential for risks within the operational structures and disciplines on multiple levels.

 

Challenge

With this type of company, the risks could be technical, operational, or legal, and arise from a range of regulated areas. This added to the due diligence process complexity of ensuring all relevant areas were identified and evaluated. In addition, the private equity firm asked RCA to assess expansion capabilities and develop an understanding of any structural limitations that could affect the financial transaction or provide leverage during the deal negotiations.

 

Approach

RCA immediately identified that a cross-functional team of technical and regulatory subject matter experts would be needed. Within 24 hours, technical functions were matched with skilled resources to study the regulatory, operational, and quality aspects of the target enterprise.

Working with the client and the material in the data room, this team quickly identified the critical risk areas. Risks were prioritized in the order of assessing the different operations. A comprehensive checklist was prepared to support the facility visits and the corporate headquarters assessment.

With preparation complete and time-limited, the RCA team was given the go-ahead to initiate the on-site corporate and facilities visits. Across a total of eight days, the team successfully completed nineteen facility visits and a corporate office assessment.

The private equity firm was provided with timely updates that they were able to integrate into the ongoing negotiations.

All findings and recommendations were compiled into a final report, resulting in a successful negotiation. Providing dependable and consistent information on a daily basis, RCA delivered recommendations that contributed to a successful negotiation.

 

Result

RCA leveraged our personnel with extensive subject matter expertise to successfully provide a comprehensive mapping of the technical, regulatory, quality, and industry findings. The final regulatory procedures report for the equity firm was utilized in negotiating the sale. Expert counsel was provided in a number of areas, including to quantify the range of potential health and safety liabilities.

Additionally, risk mapping and assessment of remediation costs enabled the client to successfully negotiate the purchase price of the medical enterprise.

 

About RCA’s Due Diligence 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® Inc. 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® Inc.’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® Inc., 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® Inc.’s 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 Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation 

Regulatory Compliance Associates® Inc. 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

 

About RCA

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

 

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

 

 

References

  1. FDA Code of Federal Regulations, Title 21, Part 210, “Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs,” April 1, 2010.
  2. FDA Code of Federal Regulations, Title 21, Part 211, “Current Good Manufacturing Practice for Finished Pharmaceuticals,” April 1, 2010.
  3. FDA Code of Federal Regulations, Title 21, Part 820, “Quality System Regulation,” April 1, 2010.
  4. U.S. Department of Health and Human Services, Food and Drug Administration, “Guidance for Industry, Process Validation: General Principles & Practices,” January, 2011.
  5. International Standards Organization, ISO Standard 13485: Medical devices—Quality management systems—Requirements for regulatory purposes. Second Edition, July 15, 2003.
  6. International Standards Organization, ISO Standard 11135: 1: Sterilization of health care products—Ethylene oxide—Part 1; Requirements for development, validation, and routine control of a sterilization process for medical devices. 2007.
  7. International Standards Organization, ISO Standard 11137-1: Sterilization of Healthcare Products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. 2006.
  8. International Electrotechnical Commission, “International Standard—IEC, 60300-3-1,” Second Edition, 2003.

Background

due diligence processWanting to purchase a medical enterprise, a private equity firm contacted Regulatory Compliance Associates® Inc. to perform a regulatory due diligence analysis of a target company within an extremely tight time-line.

The due diligence process included multiple operations in North America, Europe, and East Asia. The nature of the target enterprise presented potential for risks within the operational structures and disciplines on multiple levels.

 

Challenge

With this type of company, the risks could be technical, operational, or legal, and arise from a range of regulated areas. This added to the due diligence process complexity of ensuring all relevant areas were identified and evaluated. In addition, the private equity firm asked RCA to assess expansion capabilities and develop an understanding of any structural limitations that could affect the financial transaction or provide leverage during the deal negotiations.

 

Approach

RCA immediately identified that a cross-functional team of technical and regulatory subject matter experts would be needed. Within 24 hours, technical functions were matched with skilled resources to study the regulatory, operational, and quality aspects of the target enterprise.

Working with the client and the material in the data room, this team quickly identified the critical risk areas. Risks were prioritized in the order of assessing the different operations. A comprehensive checklist was prepared to support the facility visits and the corporate headquarters assessment.

With preparation complete and time-limited, the RCA team was given the go-ahead to initiate the on-site corporate and facilities visits. Across a total of eight days, the team successfully completed nineteen facility visits and a corporate office assessment.

The private equity firm was provided with timely updates that they were able to integrate into the ongoing negotiations.

All findings and recommendations were compiled into a final report, resulting in a successful negotiation. Providing dependable and consistent information on a daily basis, RCA delivered recommendations that contributed to a successful negotiation.

 

Result

RCA leveraged our personnel with extensive subject matter expertise to successfully provide a comprehensive mapping of the technical, regulatory, quality, and industry findings. The final regulatory procedures report for the equity firm was utilized in negotiating the sale. Expert counsel was provided in a number of areas, including to quantify the range of potential health and safety liabilities.

Additionally, risk mapping and assessment of remediation costs enabled the client to successfully negotiate the purchase price of the medical enterprise.

 

About RCA’s Due Diligence 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® Inc. 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® Inc.’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® Inc., 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® Inc.’s 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 Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation 

Regulatory Compliance Associates® Inc. 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

 

About RCA

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

 

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

 

 

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