Regulatory Compliance 黄人导航 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
If the FDA issues you a 483 inspection observation or sends you a warning letter, RCA can assist in developing a response that will be accepted by the Agency and...
21 CFR Part 11
Regulatory Compliance 黄人导航聽computer system validation (CSV) experts and software engineers have extensive experience with 21 CFR Part 11 and the GAMP5 validation model to ensure that you have the appropriate...
21 CFR Part 210 and 211
Maintaining compliance to 21 CFR Part 210 and 211 is critical to the pharmaceutical industry. Life Science companies that require assistance in establishing, maintaining, or improving their quality systems and...
Oversight Services
Regulatory Compliance 黄人导航庐聽Inc. can help with quality compliance remediation activities. We have assisted our clients with pharmaceutical oversight projects by evaluating what is needed, developing action plans and executing protocols....
Connect with RCA Today
Contact us to learn more about our regulatory compliance experts and how they can help
