Medical Devices
GMP, GDP, Compliance and Remediation
- QMS Services
- EUGMP Audit for Finished Product (FP) Manufacturing Site, Active Pharmaceutical Ingredient (API) Manufacturing Site and UK/EU QC Testing Laboratory.
- Preparation of Product Quality Review (PQR).
- Expert Support for Process Validation and Batch Size Scale UP.
- New Product Introduction.
- Expert Support for FP Analytical Method Transfer.
- Handling of Market Complaint.
- Handling of Deviation, OOS or any GMP Non-Compliance etc.
- Writing of SOPs for GMP and GDP Operations.
- Product Life Cycle Management.
- Management and Handling of MHRA and EU GMP Audit.
- Provide full remediation services through our highly skilled technical team for the client under the UK and EU National Regulatory Authority enforcement action.