Regulatory Compliance Associates® Inc. knows how quality or compliance crises can significantly impact your business—and we have the experience to manage those crises. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and solutions. We can perform a “deep dive” into any quality system or process that you feel needs a good top-to-bottom assessment.

 

While not an all-inclusive list, our Compliance Assurance Assessment services for the Pharmaceutical industry include:

 

  • Current Good Manufacturing Practice (cGMP)
  • International Organization for Standardization (ISO)
  • Quality Infrastructure
  • Corrective and preventive Action (CAPA)
  • Validation
  • Facility and Maintenance
  • Pre-Approval Inspection (PAI)
  • Data Integrity
  • Start-up Assessments

Mergers & Acquisition / 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. We can help a company make the right decision.
 
RCA Executives meeting with a new client.
 
We leverage our 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 210 and 211 Assessment
  • Good Laboratory Practice (GLP)

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