• Opening Hour: 9:00 am - 9:00 pm




We at Pragdom Enterprises understand the regulatory compliance and its impact on the quality and safety of the medicinal product and meets the expectation by:
  • Development of system for Regulatory compliance like SOP and Guidance documents.
  • Ensure to keep updating registered information as per current ICH and regulatory requirement.
  • Expertise in evaluation of change control proposed from the API supplier for DMF/CEP updation, Manufacturing site change, Analytical or R&D proposed changes including Complex Site transfer or Formulation changes.
  • End to End Regulatory Services covering development of Regulatory Strategy.
  • Support for Scientific advice for complex or innovative dosage form.
  • Managing various dosage forms – Oral Solid (IR & MR), Oral Liquids, Injectable including OTC product.
  • Expertise in Generic or hybrid MAA, Branded Generics application, FDC submission, and bibliographic application.
  • Advice for the selection of Reference product to be used in development and Bio-equivalence study.
  • We work in conjunction with contract manufacturing site to support during tech-transfer activities in line with registered information and to meet current Regulatory expectation.