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 to develop a robust long-term regulatory roadmap with input from cross-functional experts when appropriate

  • Be more credible, confident and successful when fundraising

  • Want to know how to progress efficiently and effectively

  • Do not have any or the appropriate regulatory expertise

  • Want 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 maximise 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 with input from cross-functional experts when appropriate under one roof at no extra cost

  • 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

We struggled to interpret shifting regulations, leading to time-consuming rework, costly delays and wasted effort as we tried to meet standards without a clear path forward. Ming brought the clarity and expertise we needed, helping us streamline our approach and build a compliance strategy that has made a tangible difference.

What set Ming apart was her proactive and tailored approach. Unlike other consultants, she didn’t apply a one-size-fits-all solution. Instead, she took the time to understand the specific challenges we were facing and offered guidance that was directly relevant to our needs. Her commitment to our success and depth of knowledge made a lasting impression on our entire team.

I would highly recommend Ming to any organization looking for a trusted advisor in the regulatory space. Her expertise and dedication have been instrumental in positioning us for continued success.

“

Imad Mardini, Chief Operational Officer, Psivac Limited