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Case Studies

Below is a list of recent case studies with results from our work with clients in the biotechnology, medical device, and pharmaceutical industries, as well as our international mergers and acquisitions practice. Click on the title of the study to read the full account. Contact us at info@rcainc.com for more information.

Mergers & Acquisitions

  • Time, Distance, and Technology for a Private Equity Due Diligence
  • Pre-Acquisition Technical Due Diligence
  • White Paper: Managing Business Risks During Life Science Due Diligence

 

Biotechnology

  • Production and Process Control

 

Medical Devices

  • Shelf Stability
  • Technical File Remediation
  • FDA Warning Letter Remediation
  • Manufacturing Automation
  • Process Validation Remediation
  • Product Cleaning Endotoxin Control
  • Regulatory 510(k) Analysis Development Product Cleaning/Disinfection
  • White Paper: Challenges in Design Development – Why Design Controls Make Sense


Pharmaceuticals

  • Risk Management in Product Development and Manufacturing 
  • Gap Assessment Electronic Records 
  • FDA Warning Letter Response and Remediation
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