Case studies
Proven in the field.
A selection of the programs we have carried through development and approval. Much of our work is covered by confidentiality, so further references are available on request.
Gastric-retention MR program for diabetes
Boston-based biotech · NCE · Phase 1 to 3 CMC · Approved January 2023
Challenge
A new chemical entity for diabetes that needed a gastric-retention modified-release tablet to deliver the target release profile.
Approach
Formulation development and scale-up through Phase 1 to 3 CMC, then tech-transfer for process-validation batches.
Outcome
Approved and launched in the US in January 2023.
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