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Process Development

Delivery of a drug candidate from the discovery stage to clinical phases requires a robust and well-defined process research and development plan. As per requirements, Clearsynth can either develop new synthetic routes from the beginning or modify and optimize processes provided by customers.

Clearsynth Development scientists design novel or improved methods and processes suitable for medium to large-scale production. Our scientists possess expertise in a broad range of structural classes of molecules and are able to address a wide variety of chemical synthesis and production problems.

Process Studies Include

  • Synthetic route scouting (Identify problems, non-compatible sequence and feasibility)

  • Discovery and development of new process methodologies (new synthetic routes & optimization)

  • Impurity synthesis & characterization

  • Analytical Development

  • Technology transfer and process justification document

The Technology Transfer report prepared by Clearsynth will be essential for successful transfer ofdrug candidates from discovery to clinical phase.


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