From our experience in completing projects for EU and FDA submission, at Protea we can assist you with making sure that your documentation is CMC and GMP compliant.
In particular, we can write or review Module 3 and 5 of the Common Technical Document (CTD). We can provide CMC-specific project management or author the technical documentation needed for regulatory submissions. We can also help in reviewing technical documentation, protocols and reports, with an eye to compliance to GMP and CTD regulations. In this way, we ensure your development is not delayed due to hurdles in submission to regulatory agencies.
