To gain all this information, a thorough understanding of the drug substance and the development of the drug product is necessary. For example, has the drug substance poor solubility, is it sensitive to degradation in certain environments, and is it well absorbed from the site/tissue in the body where it is supposed to be administered?
Knowledge that builds the CMC
Knowledge about product development and drug delivery is at the core of the CMC. The aim with CMC and drug development is to secure that the medicinal drug - every time it is administered to a patient - will be delivered to:
- the right place in the body
- in the right amount
- at the right time
How we can help
Our consultants will assist in advising and planning the necessary formulation-, process- and analytical development and reviewing formulation studies to achieve this. They can support with advice on appropriate excipients, manufacturing techniques, and quality control to develop the product to be ready for testing in preclinical and clinical studies and eventually for registration.
Our consultants fulfill requirements for different development phases including the following:
- Procurement of contract research and manufacturing organizations (CDMOs) for both drug substance and drug product
- Guidance of required level of quality for the current phase of development
- Elaboration and compilation of necessary CMC-documentation for application of clinical trials and registration
- Support regarding scientific publication, scientific advice meetings and due diligence assessments.