Regulatory Compliance »ÆÈ˵¼º½ offers extensive experience in quality and regulatory compliance consulting. Our pharmaceutical consultants know how to partner with executive, legal, and communication teams at all levels of a life science company.

Pharmaceutical Remediation Consulting
RCA’s remediation consulting experts help develop realistic remediation strategies that meet regulatory agency standards. They assist with FDA 483 observations, Warning Letters, and long-term risk management to ensure ongoing compliance. RCA provides support for both manufacturing operations and quality management systems, conducting thorough audits and collaborating with clients to create actionable plans for effective execution.
Regulatory Response
21 CFR Part 11
21 CFR Part 210 and 211
Oversight Services
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