Our Expertise

Share

Ask the Expert: Complying with Standards
This Video was published by PharmTech. In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow with Nelson…
Why Early FDA Engagement Is Make-or-Break for Medical...
Discover best practices for communicating with the FDA during medical device R&D, preparing meeting packages, and aligning with reviewer expectations.
Regulatory Actions Impacting Biologics
In this audio clip originally published by by PharmTech. Three regulatory actions are converging to move biologics, gene therapy, and…
Pharma Fundamentals: Biologics Development and PDA’s Technical Report...
In this episode of PharmTech’s Pharma Fundamentals, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates and a member of PharmTech's editorial…
Investigating Patient Complaints About Combination Products
In this audio clip originally published by by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried…
Ask the Expert: Enhancing Out-of-Specification Procedures
This Video was published by PharmTech. Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice…
Navigating the QMSR Transition: Expert Insights on FDA...
Explore expert strategies for navigating the FDA QMSR transition, aligning 21 CFR Part 820 with ISO 13485:2016, and managing global…
Designing a Test Plan that Works Globally: A...
Discover key strategies for building a global testing plan. Optimize regulatory submissions, reduce redundant testing, and accelerate global market entry.

Connect with RCA Today