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CGMP / Quality System Auditing
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Internal GMP Audit
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Analytical Laboratory Audit
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Quality System Design & Management
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Stability Program Design / Implementation
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- Regulatory Submission Preparation for
- Drug Master File (DMF) in CTD
- Certificate of Suitability (COS) Dossiers in CTD
- Standard Operating Procedure (SOP) Development
- Revised Schedule 'M' , WHO - GMP,
UK-MHRA , Australia - TGA , PIC/s etc. implementation
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