Regulatory considerations

Regulatory consideration is the key to optimizing the development resources for global development of API and finished products.

Assess the global regulatory landscape based on each local regulatory and market needs ( ANDA,ANDS,MA's though DCP or CP or MRP etc).
505(b)2 and Pre NDA preparations.
Collaboration between API and Drug Product companies for mutual benefit.
DMF/COS evaluation to limit the resources of its clients to bare minimum.
Mock up audits for its clients for their API/FP and BE/CT sites to preempt issues well in advance.
Formulate CMC and BE/CT related queries effectively on time.