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When you develop a new biopharmaceutical, you are required to file an IND or IMPD dossier at the regulatory authorities to obtain approval for starting a phase I human clinical trial.

The IND or IMPD dossier must provide all available information on product efficacy, product safety and product manufacturing procedures. The latter section is called the chemistry, manufacturing and controls section or CMC.

The data necessary to complete the CMC section of an IND or IMPD requires highly specialized staff, high quality R&D laboratories and state-of-the-art clean room facilities Therefore, many product development organizations decide to outsource the activities required to complete the CMC section.

Please contact [email protected] if you are interested to know more.

Or visit our website at: https://www.bataviabiosciences.com/