DPT Laboratories has added preparation of the chemistry, manufacturing and controls documents (CMC) in the Common Technical Documents (CTD) format as an optional service for customers applying for approval of new drugs.
The new service provides preparation of CMC modules 2 and 3 documentation throughout formulation and process development in the common format established by the International Commission on Harmonization for submitting NDAs to the FDA and regulatory agencies in the EU and Japan.
“An increasing number of pharmaceutical companies are choosing to format the documentation in the CTD format throughout development on an ongoing basis, rather than waiting until the end of the drug development process and having to reconstruct years of paper work,” said Kay Mary Harrell, senior director, Regulatory Affairs for DPT. “Drafting the documentation in the CTD format from the beginning of development and/or manufacturing can shorten the already lengthy drug approval process. At the end of the process, the customer has a submission-ready CMC section.”