Regulatory Affairs

Bion Clinicals has complete understanding of domestic and international regulatory

environment. Bion will be in a position to expedite the regulatory approvals, submissions and

we are showing with regulators. This adds tremendous value to our sponsors

This is with a view to shorten the product timelines, for faster approval Submissions,

lobbying for products with longer regulatory compliance lifespans and reduce risk of

non-compliance issues

 Offer support on Indian regulatory environment & requirements

 Compiling dossiers

 Executing regulatory submissions

 Preparation & submission of regulatory documents for :

 Approval to conduct clinical trial in India

 Approval to import Test Drug

 Approval to export Biological Samples

 Liaising for registration documents for our clients

 Continuous follow-up post submission with regulatory authorities

 Renewal of Import license

 Offer support on Indian regulatory requirements

 Safety reporting