Regulatory Strategy 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.