Services

Global Business Development

We provide insights and create synergies with the right international partners for sustainable growth from
Geographical Expansion
Product Portfolio Expansion

GMP / Quality Systems | Accreditation & Compliance

  • 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/EMA, MHRA, TGA, PIC/S, GCC)
  • Facilitate Indian and overseas formulations (oral and injectables) 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 Audits both in India and abroad
  • Validation activities (HVAC System, Water System, Nitrogen System and Compressed 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 up-gradation on GMP and regulatory guidance documents
  • Participate in International Regulatory Audits
  • Assist in preparing International Audit compliance responses (FD 483, FDA Warning Letters)

Global Regulatory Affairs & Approvals

  • Help prepare DMFs (CTD), IND, ANDAs (CTD, ACTD) for US and other regulated 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 participate in WHO pre-qualification programme, Geneva

Market Entry in India

We provide insights and create synergies with the right international partners for sustainable growth from

Global Outsourcing from India / Asia

We provide insights and create synergies with the right international partners for sustainable growth from

Digital and Software

We provide insights and create synergies with the right international partners for sustainable growth from