Regulatory Affairs department is key link between company, products and regulatory authorities of different countries.
We Astrozen Pharmaceuticals Pvt. Ltd. have a well experienced, young and dynamic team of Regulatory Affairs consists of elite, highly qualified professionals engaged in providing data required to assure the high Quality, efficacy and safety of our Products. We can provide clinical Trials, Impurity Profiles, DMF, BE/BA Studies for registration of our products as per guidelines of health authorities in both Regulated and Non-Regulates markets. We have tie ups with well-established study centers which are approved from local DCGI and other international regulatory authorities, to carry out Clinical / Pre-clinical studies for various dosage forms.

Our teams of regulatory affairs professionals work closely to develop and implement viable strategies to move projects from conception to approval.

  • We have requisite infrastructure & expertise to support our associates with excellent technical and Regulatory submission (ACTD,IND, CTA, NDA, CTD, DMF, ANDA)
  • Astrozen Pharmaceuticals Pvt. Ltd. has Regulatory experts for each country and region which ensures that we have up-to-date local knowledge of the submission process, specific to the country.
  • Astrozen Pharmaceuticals Pvt. Ltd. understands the significance of high quality documents to the relevant Regulatory Authorities to ensure that approvals are made in a timely fashion.
  • The Regulatory Affairs staff assigned to your dedicated Project Team work to ensure the successful and timely submission of your product application.