Case Studies
Regulatory Due Diligence
Background A private equity firm pursuing the acquisition of a global medical enterprise engaged Regulatory Compliance Associates® Inc. (RCA) to perform a comprehensive technical due diligence analysis under a highly...
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Case Studies
Pharmaceutical Development and Regulatory Submission
A global manufacturer of pharmaceuticals was facing potential expiration of a substantial quantity of API when their API manufacturer suddenly exited the relationship. RCA was asked to assist with remediating...
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Case Studies
Strategy for Pharmaceutical Submission
A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. RCA suggested a CBE 30, which they submitted to the FDA, addressing product complaints and maintaining...
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Case Studies
21 CFR Part 11 Gap Analysis
RCA was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing remediation plans, the FDA chose not to make a regulatory...
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Case Studies
FDA Warning Letter Response and Remediation
Background A mid-sized company received a 10-item FDA Form 483 and submitted an initial response. However, the response was followed by the issuance of a Warning Letter, leaving the company...
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Case Studies
Document Management System
A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document change process.
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