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510(k) Marketing Submissions and Predetermined Change Control Plans
Design Development Pitfalls in Connected Devices
Development of a Connected Device
Strategic CGMP Remediation for a Major Pharmaceutical Company
In the highly regulated pharmaceutical industry, compliance with FDA regulations is paramount to ensuring product safety and overall quality. When…
Drug Shortages and Complying with FDA’s 21 CFR...
RCA experts answer questions about the recent FDA 21 CFR 211.110 guidance document and how it relates to drug shortages.
Ask the Expert: Complying with 21 CFR 211.110
In this PharmTech interview experts discuss the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.
Drug Digest: Advances in Small-Molecule Manufacturing
In this PharmTech interview the topic of advances in small-molecule manufacturing is covered with several other experts commentaries.
The Future of MedTech and Pharma Under the...
Join our expert panel of scientists and FDA consultants as they explore the potential regulatory changes with the new administration.

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