We are able to work with both original APIs and generics. In case of NCE (new chemical entity), TBD-Biodiscovery will support you during the early drug development and preparation of clinical batches for Phase 1/Phase 2 and even later if the demand for commercial domain fits our production capacity.
If you wish to be the first one to hit the generic market when the patent protection is over, TBD-Biodiscovery is your partner of choice.
But first of all we need to have validation batches and ASMF.
This will include the following:
- Route-scouting and feasibility studies
- Development and upscale of manufacturing process (up to 10 kg)
- Full analytical support: methods development and validation
- Characterization of impurities
- Process validation
- Full CMC /ASMF (in CTD format) support
- Organization of stability studies