Regulatory Information and Facilitation Center (RIFC)
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 organizing relevant and useful events. Key activities planned:
- Services to innovators and entrepreneurs
- Information resources: A informative wiki and a physical collection
- Events: R Clinics (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
- 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 fundraising 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.