Overview

CMC (Chemistry, Manufacturing and Control) plays an important role in the market success of a drug. CMC professionals help to ensure safe and effective pharmaceutical products are released to the market.  We can offer support across all stages of the product lifecycle and have experience with a variety of dose forms. 

ELC group offers a wide range of services and experienced consultation to customers. 

Regulatory Services

  • Regulatory CMC writing Conversion of CMC dossiers in old NTA format to CTD
  • Life cycle maintenance; variations, SUPAC support
  • Expert report writing; QbR, QOS etc
  • Due diligence of dossier
  • Regulatory CMC strategy
  • Review of technical documentation
  • Assistance with API/drug substance documentation
  • Response to CMC deficiencies
  • Support for scientific advice meetings

Manufacturing Compliance

  • Review of master manufacturing documentations
  • Consultation on batch execution
  • GMP audit/GMP strategy/Trainings
  • Mock/Pre-approval inspection
  • Review of process validation documents
  • Compliance check with EMA/FDA/ICH guidance

Quality Services/Batch Release Services

  • Services of Qualified person (QP) 24x7
  • Batch release facilities
  • Stability: Help with stability programme design, Review of stability programme and data