Specialized quality, validation, audit, and regulatory support for API and finished dosage form manufacturers.
Overview
Active Pharmaceutical Ingredient (API) and Finished Dosage Form (FDF) manufacturers operate in a highly regulated environment where product quality, data integrity, contamination control, and regulatory compliance are critical.
MGS supports API and finished dosage form manufacturers with specialized services across GxP audits, quality and compliance, qualification and validation, regulatory support, computerized system validation, data integrity, and inspection readiness.
Our experts help clients identify compliance gaps, strengthen quality systems, improve operational controls, and maintain readiness for national and international regulatory inspections.
Regulatory Challenges
API and finished dosage form manufacturers may face challenges such as:
- Compliance with ICH Q7 and applicable GMP requirements for APIs and intermediates
- Sterile and aseptic processing requirements, including applicable EU GMP Annex 1 expectations
- Data integrity across laboratory, manufacturing, and computerized systems
- Cross-contamination control and appropriate segregation
- Qualification and validation of facilities, utilities, equipment, and processes
- Effective management of deviations, CAPA, investigations, and change controls
- Maintaining reliable documentation, traceability, and lifecycle controls
- Sustaining inspection readiness across multiple regulatory requirements
How We Help
MGS provides specialized quality, compliance, validation, and regulatory support through:
- GMP Audits and Gap Assessments
- Process Validation and Cleaning Validation Support
- Equipment, Utility, and Facility Qualification
- Data Integrity Assessments and Remediation Support
- Quality Management System Support
- Computer System Validation and GxP Digital Compliance
- Regulatory Documentation and Submission Support
- Inspection Readiness and Mock Inspections
- GMP and GxP Training
