Formulation Development
We manage bioequivalence and clinical trial strategy on behalf of our partners - from protocol design and CRO selection to investigating and resolving failures.
Bioequivalence & clinical trials
Right design of study protocols
Organising and managing CROs
IVIVC and IVIVR studies
BE / CT failure investigation and reformulation strategy
BCS waivers
Impurity qualification
Genotoxicity evaluation
Clinical supplies
cGMP manufacturing services for oral solids (tablets and capsules) for scale-up and pilot BE batches.
Content to be provided by FTF Pharma: details of clinical supply manufacturing, packaging, labelling and batch sizes.