Navigating Quality Systems with Confidence
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Consulting Services
GMP/Quality Systems
GMP/Quality Systems
GMP/Quality Systems
- Help create new green field manufacturing facilities anywhere in India and abroad ( from Concept to Commissioning).
- Renovations of existing manufacturing facilities to make them Global Regulatory compliant (US FDA, EU, MHRA, PICs and TGA etc.).
- Perform GAP Analysis of entire Quality Management System of the firm.
- Help improve Quality Management System.
- Implement Quality Risk Management in to their Quality Management systems and Validation Program.
- Perform GMP Pre-audit of Manufacturing facilities, R&D Labs, BE Centre etc.
- Help improve Document Management System.
- Help improve functioning of QC Laboratories.
- Perform Vendor Audit for the clients in India and abroad.
- Validation activities (HVAC System, Water System, Nitrogen System and Compress Air System etc.).
- Help improve Equipment Qualification and Verification procedures.
- Validation of Microbiological Methods.
- Help implement software systems in QC lab, QA and other operations.
- Existing software validations (SAP; LIMS, Track wise etc.).
- Help improve productivity and provide suggestions to reduce energy cost and reduce wastages.
- Product development and Technology transfer.
- Employee Training for their Regulatory knowledge up-gradation on GMP and Regulatory Guidance documents.
- Participate during International Regulatory Audits.
- Assist in preparing International audit compliance responses (FD 483, FDA Warning Letters etc.).
Regulatory Affairs
GMP/Quality Systems
GMP/Quality Systems
- Help prepare DMFs ( CTD) , IND, ANDAs ( CTD, ACTD ) for US and other Regulatory Markets.
- Review of Dossiers for their correctness and completeness.
- Help prepare Product Registration Dossiers in ROW Market.
- Help clients prepare query responses on submitted dossiers.
- Help improve International Business.
- In licensing and out licensing of products.
- Help participate WHO Pre-qualification program, Geneva.