• Phone: +91 9881760231
  • Email: bd@jisaipharma.com

We do onsite visits to provide the scientific and regulatory services to customers for developing new products for regulated markets, resolving the scaleup issues in GMP and proving the CAPAs appropriately. We also undertake the Drug Master Files (DMFs)/CEPs preparation and Submission to respective regulatory agencies like USFDA, EDQM and PMDA, KFDA etc. We also do the gap analysis of existing DMFs, corrective actions and submitting the final DMFs to agencies. We also provide the regulatory query responses scientifically to get DMFs/CEPs approval/acceptance from regulatory agencies.