About

Regulatory Information and Facilitation Center (RIFC)

The Regulatory Information and Facilitation Center (RIFC) is joint initiative of the Venture Center and BIRAC under the BIRAC Regional Bio-Innovation Center (BRBC) program.

The RIFC aims to assist bio-entrepreneurs in planning, seeking and securing regulatory approvals.

The RIFC plans to achieve this by providing information in an entrepreneur-friendly manner, providing access to experts and regulators, providing access to practical insights from other entrepreneurs, providing services and organising relevant and useful events. Key activities planned:

  • Services to innovators and entrepreneurs
  • Information resources: A informative wiki and a physical collection
  • Events:  RClinics (Regulatory Clinics) | Workshops | Annual Conference | Base Camp focussed on Regulatory Approvals
  • Over time, we hope to put out white papers and guidance notes.

Scope of activities by industry sectors:

  • Medical products: a) (First priority) Medical devices, b) Diagnostics, c) Therapeutics, d) Preventives
  • Agricultural products
  • Food and nutrition products
  • A few other bio-based products

Jurisdictions:

  • India
  • Over time, we plan to look at US and EU norms as well

Scope of activities by nature of assistance:

  • Planning the regulatory pathway  for scope, actions, timelines and resource requirements. This is to help entrepreneurs bring greater detailing in their plans and fund raising goals.
  • Opinions and reports
  • Information bank on laws, rules, guidelines, service providers etc
  • Networks and referrals
  • Document preparation advisory
  • Forums to access regulators, regulatory experts, industry experts and peers with past experience.

             BRBC