Conduct independent audit to evaluate Quality GMP Compliance for Non Sterile / Sterile products, API, intermediates, excipients and packaging components.
On site customized support to new facilities
Provide practical implementation of pharmaceutical quality system and quality culture to meet various regulatory requirements
- WHO pre-qualification GMP inspection preparation,
- USFDA pre-approval
- PIC/S compliance solutions
- Russian Good Manufacturing Practices
- Indian National Regulatory Authority
Facilitate coaching and training of personnel at all levels within the organization in the principles of competence and Quality culture
GMP up-gradation support for WHO, USFDA, PIC/S and EMA regulated pharmaceutical manufacturers and distributers
Pharmaceutical Quality Technical support includes validation, equipment/instrument qualification, training, coaching and competency development program
Our end-to-end process (Conception to Completion) expertise includes site evaluation, master planning, architectural design, engineering, procurement, and construction of plant.
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