Reluctance to compute tolerance intervals
- Needed support with the preparation of Module 3 and corresponding Module 2.3 documents for drug substances and drug products:
- To reflect the current status of manufacturing process and state of the scientific art analytical procedures
- To close gaps and achieve GMP compliance of regulatory documentation.
- Required on-going lifecycle management for all drug product licences needed.
Market specific CTA applications for a multi-country EU Phase III clinical trial
- Assistance required to review core documentation.
- Authoring of local documentation for country specific submissions.
- Assistance with competent authority and ethics committee communication.
- Support with handling of substantial amendments to competent authorities and ethics committees, as required.
Support for timely approval of a Phase II clinical trial in the US and UK
- Required assistance in IND authoring, eCTD publishing and FDA Agent activities for submission to FDA.
- Alongside support in authoring of IMPD and local documentation required for submission to MHRA.