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InterProQRA – Field-Proven Regulatory Guidance
InterProQRA is Interchem’s sister company whose expertise in CGMP compliance and FDA regulatory adherence was earned through decades of front-line pharma manufacturing experience. In addition to supporting Interchem’s supply-risk mitigation program, InterProQRA provides comprehensive solutions to pharmaceutical and biologic companies of every size around the world.
Regulatory expertise from front-line experience
InterProQRA investigators bring decades of boots-on-the-ground FDA evaluation and enforcement experience and years of consulting work for pharmaceutical clients.
The benefit to you? The InterProQRA team delivers insight and foresight borne from working both sides of the Quality table.
Expertise for any regulatory need
Our teams have directed inspections, participated in regulatory actions, and built manufacturing expertise in firms that manufacture all categories of dosage forms and APIs that are distributed in the United States. Around the corner or across the globe, InterProQRA knows how to deliver regulatory success.
InterProQRA services include:
• CGMP compliance solutions
• Enforcement guidance
• Training programs about CGMP and how to interact with the FDA
• Design guidance and validation audits for construction projects