Making Your Regulatory Success A Reality

Who this is for?

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

  • Have completed The Smarter Regulatory Health Check

  • Have mapped out their long-term regulatory roadmap

  • Does not have the regulatory capabilities or resources

  • Is not used to dealing with high levels of complexity

  • Wants in-depth help with a specific point early on their regulatory roadmap

Examples of what we help with

  • Helping you to proceed to your first or next clinical trial

  • Scientific advice

  • Pediatric strategy (PIP/PSP)

  • Securing PRIME, RMAT, Breakthrough including initial and subsequent interactions

  • Organisational gap analysis

  • Bespoke 1-2-1 leadership coaching

  • Helping you to hire the right permanent Regulatory Head of Function with our trusted partners

How you benefit

  • You’ll feel relaxed knowing that you’re in a safe pair of hands

     

  • You’ll receive clear, honest feedback to enable you to make informed decisions

     

  • You’ll maximise your chances of success

     

  • You’ll have more time to focus on other priorities

Examples of past projects

  • US Regulatory strategy for an advanced therapy with a co-developed medical device for a CNS indication with RMAT designation

  • US/Europe regulatory strategy for a novel product in anti-infectives

  • Multi-dimensional gap analysis regarding the organisation’s readiness for the next stage of development and areas for growth

  • Mentored the Head of Regulatory

  • Conducted clinical trial application (CTA) gap analysis and helped client to secure approval, enabling them to progress to their first clinical study.

What’s included?

  • Initial strategy and planning sessions based on agreeing the outcome

  • Regulatory progress check-ins and support during project execution

  • Introductions to trusted partners when appropriate to aid operational execution

For more information

I hired Ming for her regulatory expertise and to guide and mentor the Head of Regulatory who found the coaching really helpful, and significantly increased her self-awareness. I appreciated Ming’s integrity, honesty, and positive challenging.  She brought clarity, order, and structure to the project. Apart from delivering results, she demonstrated a way of working which the Team appreciated.  Her organisational gap analysis was very truthful and constructive - clearly identifying the gaps, problems, and opportunities, and including helpful suggested action points.  Ming also helped to demonstrate the value of Regulatory Affairs within the organisation.

Ming is a special kind of consultant because unlike other consultants I have worked with over 20 years in the industry, she really cares about her work and about finding the right way forward. This truly adds value to the company. I recommend Ming for any dynamic, innovative SMEs who are open to different ways of working. I’d love to work with Ming again!

“

Yuri Martina, Chief Medical Officer, Destiny Pharma

Ming has created and provided a safe space, which enabled me to open up and talk honestly and transparently. This is needed if you are hoping to learn and develop. She is non-judgemental and is not afraid to challenge you or your thinking in a positive way.

As she is open with her experiences and feelings, it creates a neutral sense of equality.

I can’t thank her enough for her openness and guidance.

“

Head of Function, Biotech Start-up