The entry of any pharmaceutical product onto the market is dependent on submission of extensive documentation and successful review of that documentation by the relevant authorities. It is essential that this documentation is complete to required standards.

An element of that documentation, commonly known as the CMC (Chemistry, Manufacturing and Controls ) and more recently the ICH CTD (Common Technical Document) - Module 3 Quality, considers the manufacture and characterisation of the API (drug substance) and drug product.

In consideration of development, manufacturing, characterisation and data generated by those activities, Biotecnol can provide the required resources for establishing documentation to the appropriate standard.