Pharmaceutical and chemical – API development

From research to patient

The Active Pharmaceutical Ingrediant (API) is the starting point of the pharmaceutical product development process. If the API in your product is already used in established marketed medicines, then there will be at least one synthetic route and a commercial supply source. However, if the API is new, the route to market will need to be established by specialist contractors and a source of supply will need to be identified.

Depending on the contractors involved, you may require GMP assistance and help to upscale production before either phase III or commercial quantities of API can be supplied. It is rare for only one contractor to work on a project from its inception and there may be more than one change of contractor before commercialisation is achieved.

PDS experts will work with your company to identify suitable contractors at all stages of the development process and help you select the right API partner for each stage.

API services

PDS experts will assist you with:

  • Contractor selection for all stages of chemical synthesis, for both NCEs and generic products
  • Sourcing of raw materials and intermediates from gram to ton scale made to GMP requirements
  • Process development and technology transfer to manufacturing scale anywhere in the world and supervision to ensure GMP compliance
  • Generation of correct, accurate documentation for regulatory submission at both Clinical Trial and Marketing Authorisation Applications

PDS will maximise the full commercial potential of your products or technologies

Our services include:

  • Identifying suitable and cost effective contractors for Clinical Trial Material manufacture, packaging and labelling
  • Manage product development from CTM to Production scale including supervising the generation of CMC data required for a successful Marketing application
  • Set up secondary product supply chains including API, packaging materials, product manufacture and labelling
  • Obtain import approvals and set up pre-wholesaling and distribution arrangements tailored to meet your particular requirements
  • Sourcing and importing materials, including active pharmaceutical ingredients from China and India
  • Drop shipment
  • Pharmaceutical and chemical process consulting
  • Biocatalysis
  • Contract chemistry R&D and outsourcing manufacturing
  • CMC project management
  • Formulation and packaging
  • Process hazard assessment
  • Environmental protection
  • Safe handling of highly potent substances (primary and secondary manufacturing)
  • GMP standards
  • Interim management
  • Training
  • Supplier auditing
  • Technical research and editing

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