Services

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.