CMC - right drug in best formulation and quality

CMC (Chemistry, Manufacturing and Control) represents the basis for every new medical entity on its way to the market: A compound, a dosage form and suitable packaging have to be manufactured, quality controlled, stored and distributed. This is highly complex field finally leads to successful transfer to market supplying units. Life cycle management activities with formulation innovation guarantee strategic and competitive positioning.
  • CMC development and specific aspects of galenics and analytics for
    • small molecules (all structures)
    • biologicals (antibodies, proteins, cell- and gene therapy,...)
    • radiopharmaceuticals
  • Lean CMC development to optimise investment
  • Independent CMC project and program evaluation and optimisation
  • CMC due diligence (projects and companies)
  • Life cycle management
  • Selection and management of CMC-contract partner (CROs, CMOs) incl. trouble shooting and audit
  • Pharmaceutical expert (Regulatory CMC summary documentation and individual reports)
  • Qualified person
  • CMC risk management
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actual version 27.02.2018