- QA/Quality Control Staff Augmentation
- Policy, SOP & Batch Record Review, Preparation & Optimization
- Quality System (QS) Development, Assessment & Optimization
- Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution
- Training – FDA, GMP, QSR, DQSA, USP <795>, USP <797>, Validation, etc.
- Third-party GMP & GLP Compliance Auditing
- Mock FDA/International Regulatory Agency Inspections & PAI Readiness
- Due Diligence Compliance Inspections, Audits & Assistance
- FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation
As a Contract Development Manufacturing Organization (CDMO), the senior staff of quality, compliance and program/project management professionals at GAP take a proven, pro-active tactic to serve our clients’ specific QA and compliance circumstances. We ensure their quality and regulatory operations are in compliance with current industry standards and FDA, Health Canada, EMA, and other potential notified bodies as well as the international regulations (International Conference of Harmonization). As a leader in the regulatory environment, rest assured GAP is the compliance company of choice for the pharmaceutical, biotech and medical device industries.
Contact us for more information.