- Bulk API supply for the manufacture of licensed medicines, managing long supply chains and lead-times through to timed local deliveries
- Product; technical and regulatory support for New Product Development
- Second source or alternative source with proactive change control management
- Low volume API supply for Specials manufacturers
- R&D quantities for Contract Research Organizations and Formulation Development
- Pilot or Small-scale production for Process Validation or Clinical Trials Manufacture
- Impurities and reference standards
- The basic requirements of Good Distribution Practice underpin all of the above, but we have direct experience and understanding of the specific demands and requirements of each sector to ensure a smooth process.
Although the requirements of transparency in the supply chain mean source and end-user of an API must eventually be known to each other, perhaps you don’t want the market to know of your initial interest in a product. We have experience of managing confidential initial source identification and validation prior to disclosure under confidentiality of the final customer.
Due Diligence and Supplier Selection
Are you single sourced and want to look at options for a second source? We can provide full due diligence on the available sources to help you identify not just who makes a product, but who is the best choice for you.
We have decades of experience judging suppliers and informing our process of supplier selection based on a number of intangibles that are usually invisible from a company’s literature. We share some more of our thoughts on supplier selection on our Articles page.