Summit provides strategic advice, training and auditing of the production of preclinical and clinical supplies of new drug or biologic candidates at our clients’ facilities. Summit staff can outsource the manufacturing and formulation needs on behalf of our clients, including vendor identification, contract negotiation, and management of the manufacturing from process development to scale-up through release of the GMP material. Summit can lead the process of determining the appropriate release tests and specifications based on the FDA and ICH guidelines, batch-to-batch production information and will review the batch records prior to release. The Summit staff and its network of experts can prepare pre-IND CMC sections, as well as the written section 7.0 for the IND submission to the FDA.   Summit’s areas of experience span a variety of chemical classes and includes natural products, small molecules and biologics, including gene therapies. 

• CMC Services Include:
• Training & Auditing for Internal Manufacture of Preclinical & Initial Clinical Materials
•  External Production of Preclinical Supplies
•  Scale-Up and Process Development
•  Bulk Active cGMP Manufacturing
•  Formulation Development
•  Finished Product cGMP Manufacturing