Formulation Development
Regulatory strategy is the key to optimising development resources for the global development of APIs and finished products. We help partners choose the right regulatory pathway for each market and prepare for it well in advance.
Regulatory strategy services
Assessment of the global regulatory landscape based on each local regulatory and market need (ANDA, ANDS, MAs through DCP, CP or MRP, etc.)
505(b)(2) and pre-NDA preparations
Collaboration between API and drug product companies for mutual benefit
DMF / CEP evaluation to keep client resources to the bare minimum
Mock-up audits of client API / FP and BE / CT sites to pre-empt issues well in advance
Effective and timely responses to CMC and BE / CT related queries
Dossier development