Challenge

A 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 project team responsible for the drug's development, providing guidance and hands-on support 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)

Product Development Services

Our expert teams are ready to support you through every step of the pharmaceutical product development process, leveraging our scientific, clinical and commercial expertise to help you maximize value at each stage.