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Regulatory Service

Entering a vast field of pharmaceutical products into international markets requires a detailed understanding of complex regulatory requirements. Biozenta’s Drug Regulatory Affairs (DRA) team assist company in planning and managing their pharmaceutical and medical product development programs and regulatory requirements. Biozenta ease the process of obtaining rapid approvals for the products by defining country-specific regulatory strategies early in product development and removing potential roadblocks to a successful product launch.

Biozenta’s Regulatory Services include:
  • Regulatory team consists of highly qualified personnel engaged in providing data required to assure the high Quality, efficacy and safety of the Products.
  • Biozenta can provide, Trials data, FDA Certificates and BE Studies for registration of its products as per guidelines of health authorities in most countries.
  • Biozenta has successfully completed CTD and eCTD submissions for its range of products in various countries.
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