Pharma manufacturing consultancy for a company developing a novel small molecule

Challenge

A small biotech company was developing its first oral compound — a novel small molecule. The company needed support in taking the compound to first-in-man studies and Phase II clinical trials.

Solution

Our CMC consultant joined the virtual team responsible for the development, applying a wealth of expertise in several key areas:

  • drug substance characterization, including polymorphism and salt selection studies, development of analytical methods and stability testing
  • pre-formulation studies as part of dosage form selection
  • designing and developing a formulation for Phase I studies, which could be readily modified for Phase II trials
  • selecting and managing chief research officers and chief marketing officers responsible for CMC activities
  • providing input into the specifications for drug substance and product
  • compiling CMC data for the IMPD (Investigational Medicinal Product Dossier)
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