Regulatory Due Diligence

Each successful M&A or Brand acquisition, purchase of Drug Substance or Drug Product,  contracting-in of manufacturing services requires a very high level of review of target for its technical capability, data generated and regulatory documentation available.

Our services in this area include

  • Regulatory framework and technical capabilities of target companies
  • Review of regulatory documentation on Finished Dosage forms & APIs of the target companies/brands
  • Overall regulatory & quality due diligence of API suppliers as well as contract manufacturers
  • Advisory on CMC data generation for successful filing
  • Regulatory Review of 3rd party manufacturers within & outside India
  • Vendor audit (Technical)

Other Services

s

Subscribe newsletter