Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. Drug discovery solutions are provided in form of fee-for-service work, integrated drug discovery alliances, development partnerships, licensing of innovative drug candidates and consulting arrangements.

Our Integrated Chemistry, Manufacturing and Control capabilities fully support drug substance and drug product development and GMP manufacturing from FIH to Phase III clinical development programmes on behalf of our partners around the world. Our teams are composed of multi-disciplinary, industry-leading scientists who possess integrated knowledge of every step contained within CMC development activities, from laboratory to commercial scale for both API and drug product. Straightforward, continuous processes from API to pre-clinical data and clinical supply enable end-to-end development of new chemical entities, without the need to align different providers. This allows time optimisation and risk mitigation for each single development project, in the capable hands of our expert project management professionals.

Our integrated CMC capabilities include:

• API polymorph screening, salt-selection, co-crystals screening
• API route scouting, process development and scale-up
• API GMP manufacturing
• Solid state characterisation
• Pre-formulation
• Drug product formulation prototyping and development
• Drug product process optimisation, scale-up and transfer to GMP production
• Clinical manufacturing
• Commercial manufacturing for small volume/niche product
• Analytical development and quality control
• Project management, quality assurance, consultancy

Our teams have proven expertise in both conventional and bioenhanced oral formulations and inhalation development and thought leadership in Accelerated Stability Assessment Programs (ASAP).