Confidence Beyond Compliance

Our chemistry, manufacturing and controls (CMC) group provides regulatory guidance in setting specifications, method development and validation of documentation. We can help you build a positive relationship with EMA, FDA or your local health agencies. Whether it is a case of first-time submission, change control or maintenance throughout the life-cycle, our multi-disciplinary teams take care of GxP, technical writing, regulatory strategy, change control and submissions on a global basis. We have a great record of success in supporting your CMC needs – both chemicals and biologicals.

We can support you with:

  • Product scope includes human and veterinary medicinal products comprising all types of APIs (chemicals, biologicals, biosimilars, herbals & homeopathics)
  • Strategic consultancy during pharmaceutical development and life-cycle management
  • Compilation of quality dossiers (ICH and non-ICH)
    – CTD modules 3 and 2.3
    – IMPD, IND
    – ASMF/DMF, CEP
    – Normative document
  • CMC and technical writing
  • CMC maintenance support: change control and quality variations
  • Gap analysis / due diligence (e.g. in-licensing activities)
  • CMC and GMP compliance
  • Optimization of the supply chain
  • GxP services (GMP, GACP, GDP) including audits