Regulatory Strategy

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.
Regulatory Strategy