Rapid progression of drug candidates through the pipeline brings new challenges to pharmaceutical companies; the long-term provision of drug substances relies on the availability of robust synthetic routes.  But, discovery routes are rarely suitable for direct scale-up.  It must also be appreciated that the choice and efficiency of the synthetic route impacts the impurity profile of the drug, and affects the long-term cost of goods.

ChemPharmaServe provides expertise in devising and implementing strategies to satisfy both immediate and long-term drug supply needs by outsourcing including:

• Identifying suitable contractors for process development

• Negotiating contracts

• Route selection and development

• Setting up viable technologies for the API synthesis

• Ensuring favourable cost of goods

• Supply chain management

• Sourcing cGMP production facilities

• Managing API production and regulatory compliance

• CMC dossier compilation for regulatory submissions