Our CMC work covers the spectrum of drug development to commercialisation. A number of recent projects within our portfolio include:

• Support in development of CMC strategy, provision of technical advice with assembly and review of IND CTD submissions for Japanese companies.

• Provision of technical direction and coordination of a complex synthesis of a small molecule (14 steps) at a CRO in Europe on behalf of an investment client.

• Completion of a technical analysis for a specific dosage form and identification of potential commercial opportunities. This exercise required critical evaluation of technologies (current and emerging) and globally marketed products.

• Provision of strategic and technical support for early development of a start-up company’s compound. This included facilitation and representation at a pre IND meeting with the FDA and filing the IND.

• Development and implementation of several CMC/Regulatory training courses for customers and organizations around the world, e.g. Mexico, Amsterdam, Bosnia, Latvia, USA, Ireland & Brazil. These have included Technology Transfer, Pre-Approval Inspections, SUPAC & Post Approval API Change Control.

• Provided technical and logistical support to several USA Universities in advancing their compounds through the IND process and also assisting in developing a strategy for a technology park.

• 'Due diligence' exercises covering potential opportunities for a number of clients.