Human Health

cGMP projects at Pharmatory generally begin at an early developmental stage and the produced materials are used for preclinical and/or clinical testing. Pharmatory manufactures both small molecule intermediates and final APIs. The cornerstones of our operations are long experience in human health APIs and understanding our customers’ needs and requirements.

Synthetic development

Synthetic Development

  • Route scouting
  • Feasibility studies
  • Development of synthetic routes
  • Development of analytical methods
  • Synthesis of compounds in med-chem scale
  • Metabolite synthesis
  • Preparation of standards / reference substances
  • Impurity profiling and synthesis

Process R&D

Process R&D

  • Process development
  • Design of experiments (DoE)
  • Process scale up
  • Process optimisation
  • Identification of critical process parameters

GMP Manufacturing and Analytical Services

GMP Manufacturing and Analytical Services

  • cGMP manufacturing of APIs and key intermediates
  • Process validations
  • Analytical method evaluation
  • ICH stability studies
  • Degradation studies
  • Process and technology transfers
  • Validation transfers

Radiolabelling

Radio Labelling

  • Route development for isotope labelling
  • Synthesis of stable and radioactive labelled substances
  • cGMP isotope labelling

Regulatory Support

Regulatory Support

  • Full CMC package
  • Drug master files
  • Comprehensive reporting