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. 

Team and Experience:

ELC group is has a very knowledgeable CMC technical team with over 25 years of experience. Our experts have a detailed understanding of all areas of CMC including production, quality assurance, formulation & analytical method developments.

We have CMC experience with different pharmaceutical forms such as Solid orals, injectables (sterile solutions, powder for injections, complex injectables, pre-filled syringes & multi dose vials), MDIs, DPIs, combination drugs, oral solutions, diagnostic kits, Ophthalmics, liquid anaesthetics, dermal preparations etc. We also have good experience with biologics and biosimilar applications

The benefits

ELC Group's CMC services will allow you to:

  • gain greater knowledge of the quality issues affecting your product
  • develop increased awareness of regulatory expectations
  • recognize issues in regulatory and plant documentation
  • understand the successful filing strategy
  • identify critical pitfalls in dossier preparations
  • receive guidance on changing legislation
  • get advice on critical CMC issues on a wide range of dosage forms and molecules
  • help you to evaluate the dossier from assessors point of view