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.

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Want to know more how we can assist with your custom quality and compliance needs?

Contact Us