The Smarter Regulatory Health Check
Who this is for?
Early-stage biotech start-ups at nonclinical to Phase 1/2 or pre-seed or seed stage who:
Want a quick reality check from an independent expert
Need an unconventional regulatory approach
Do not have any or the appropriate regulatory expertise
Want to be more credible, confident and successful when pitching
How you benefit
You’ll receive an independent objective sounding board or second opinion from a trusted, senior regulatory expert
You’ll be better prepared for pitching and any tough regulatory questions
You’ll be clearer about what the priorities are and what opportunities could be maximised
You’ll be more aware of what your gaps, challenges and organisational interdependences are so that you can proactively and efficiently address these.
When appropriate, introductions to trusted experts and partners to aid operational execution saving you time and money
Two calls with us including a kick-off meeting and a debrief to discuss our findings.
A regulatory health check report which gives you a starting point to develop your regulatory roadmap to commercialisation.
What’s included?
For more information
Her (Ming’s) organisational gap analysis was very truthful and constructive - clearly identifying the gaps, problems and opportunities, and including helpful suggested action points.
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Chief Medical Officer, mid-stage small biotech
Ming Ewe has been very helpful with understanding the necessary regulatory considerations that are required for our spin-off. She is very knowledgeable in regulatory affairs and helpful with advice on how to proceed forward. She is very easy to work with and I look forward to our continued collaboration moving forward.
“
James Dooley, CEO, Aila Biotech Limited
