Regulatory Compliance Associates® Inc. knows how quality and compliance crises can significantly impact your business—and we have the experience to manage them. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and solutions.

 

  • cGMP
  • ISO
  • Quality Infrastructure
  • CAPA
  • Validation
  • Facility and Maintenance
  • PAI

 

Mergers and Acquisitions / Due Diligence

When a life science company considers a merger or acquisition, it is easy to think of the deal’s risk as a potential conflict with the FDA or its equivalent in other countries. The due diligence team looks for 483s, Warning Letters, notified bodies and findings, and product recalls. But more often, the real reasons a deal doesn’t deliver value are strategic, cultural, or technical. It’s these value-destroying areas that need to be explored during due diligence.

 

RCA leverages its global experience with acquisitions and divestitures to navigate the gray areas of due diligence and help eliminate uncertainties often inherent in a complex deal. These include:

 

  • Regulatory Due Diligence
  • Quality Due Diligence
  • Facility / Equipment Assessment
  • Personnel Assessment
  • Risk Identification and Mitigation Planning
  • Post-merger Integration

Additional services related to assessments include:

 

  • 21 CFR Part 11 / Annex 11 Assessment
  • 21 CFR Part 820 Assessment
  • ISO 13485 Assessment
  • ISO 9001 Assessment

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