FDA and Industry Veterans
The InterProQRA team delivers decades of domestic and international FDA and industry experience in quality and regulatory FDA compliance.
It’s this blend of experience that enables the team to meet all compliance and regulatory challenges from the most comprehensive viewpoints to deliver real-world, sustainable solutions.
The InterProQRA Team
Mike leads the team, bringing 20 years of experience in quality and regulatory affairs including regulatory submissions, preparing facilities for inspection, bringing facilities into compliance, and implementing corrective action remediation.
- Quality system development for manufacturing facilities and virtual pharma companies
- Regular correspondence with regulatory agencies for proactive and/or remedial compliance activities
- Software implementation and related qualifications
- Auditing of API and pharmaceutical dosage manufacturers
- Preparation of API and dosage-form manufacturing sites for FDA inspection
Throughout his FDA experience at CDER, OMPQ, and DMPQ, colleagues sought Doug for guidance on the toughest challenges. Doug led evaluation, inspection, and enforcement programs and designed training programs for FDA and industry personnel in a variety of domestic and international settings.
- Go-to FDA resource for inspection and enforcement strategy for multiple pharmaceutical dosage forms
- Trained FDA and industry staffs on topics including parenteral manufacturing and domestic and international inspection and enforcement
- Expertise with Data Integrity and Application Integrity Policy issues
- Represented FDA during high-profile meetings with industry representatives
- Extensive experience with manufacturing issues, eg, water systems, facilities and equipment, aseptic processing, cross-contamination
Melissa led teams through inspections of domestic and foreign facilities that frequently housed exceedingly complex manufacturing processes. A multi-award-winning FDA pre-approval manager in the Baltimore District Office and CDER, Melissa helped develop the current CDER inspection tracking program and helped write CGMP policy. Several years as a consultant for pharma clients allows Melissa to see quality, compliance and regulatory issues from all angles.
- Extensive foreign and domestic experience covering all dosage forms and testing laboratories
- Helped launch and refine the current drug pre-approval program
- Recipient of highest FDA honors: Hammer Award and Outstanding Achievement Award
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