We offer consulting services to both APIs and Formulations manufacturing companies in India and abroad in the following areas:
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).
- Facilitate Indian and overseas formulations (oral and injectibles) manufacturing facilities with attaining EU GMP approvals
- Perform full-scale GAP Analysis of end-to-end Quality Management System.
- Help improve Quality Management System.
- Implement Quality Risk Management and Validation Programmes.
- Perform GMP pre-audit of Manufacturing facilities, R&D Labs and BE Centre.
- Help improve Document Management System.
- Help improve functioning of QC Laboratories.
- Perform Vendor Audit both in India and abroad.
- Validation activities (HVAC System, Water System, Nitrogen System and Compress Air System).
- 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).
- Help improve productivity and provide suggestions to reduce energy cost and reduce wastage.
- Product development and technology transfer.
- Employee Training for regulatory knowledge upgradation on GMP and regulatory guidance documents.
- Participate in International Regulatory Audits.
- Assist in preparing International audit compliance responses (FD 483, FDA Warning Letters).
Regulatory Affairs
- Help prepare DMFs (CTD), IND, ANDAs (CTD, ACTD) for US and other regulatory markets.
- Review of dossiers for correctness and completeness.
- Help prepare Product Registration Dossiers in ROW Market.
- Help clients prepare query responses on submitted dossiers.
- Help improve International Business.
- Assist with In licensing and out licensing of products.
- Help participate in WHO pre-qualification programme, Geneva.