For over 15 years, PDG has helped pharmaceutical firms achieve and maintain compliance with global Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and pharmacovigilance (PV) standards.
PDG takes pride in the fact that none of the multiple clients we have prepared for FDA inspections have ever received a resulting 483. We recognize that delays caused by unplanned audits or unanticipated inspection results can be costly.
Whether planned or unexpected, proactive or reactive, PDG is known for successful and nimble responses to our clients’ regulatory needs, and is positioned to address both pre- and post-approval preparedness concerns related to your drug product, manufacturing facilities, analytical laboratories and suppliers including:
- FDA Biennial, Pre-approval and For-cause Inspections: Preparation and Response
- On-site GMP audits & Mock FDA Inspections
- Supplier Audits/Qualification
- Quality Manuals; Compilation of SOPs Across Functional Areas
- Product Safety Reviews
- Form 483 and Warning Letter Response
- Field Corrections, Recalls, Hazard Analyses
- Dispute Resolution