Your
Smarter Regulatory Roadmap to Success!

Who this is for?

Early-stage biotech start-ups at nonclinical to Phase 1/2 or pre-seed or seed stage who:

  • Have completed the Smarter Regulatory Health Check

  • Want help with developing a robust long-term regulatory roadmap

  • Wants to know how to progress efficiently and effectively

  • Do not have any or the appropriate regulatory expertise

  • Wants to save time and money

How you benefit

  • You’ll feel more in control and confident in talking about your regulatory roadmap with key stakeholders including investors

  • You’ll be clear on the priorities

  • You’ll have a proactive regulatory risk management strategy

  • You’ll be maximising your chances of success by adopting a Smarter approach which aligns your regulatory, organisation and people

  • You’ll have the foundations for your initial multidisciplinary interaction with Regulators if you’re successful in securing expedited regulatory mechanisms (Breakthrough/RMAT, ILAP, PRIME)

  • You’ll feel a sigh of relief knowing this has been done!

  • Follow-up support and accountability as we build on the results of the Health Check

  • A clear step-by-step regulatory roadmap

  • Know how to cleverly fast-track your product and access additional support from the Regulators

  • Be Smarter in moving towards your next milestone by aligning regulatory, people and organisation

  • If appropriate, a clear plan of when and how to build your Regulatory Function

  • Introductions to trusted partners to aid operational execution

What’s included?

For more information