We offer dynamic, intelligent support covering regulatory strategy, organisational systems and staff development to companies in the biotech sector.

You are here

because

you want to

Have a winning regulatory strategy

Successfully attract funding

Confidently progress towards commercialisation

You’re confused about what to do because your promising, innovative product is challenging the drug development and regulatory norms.

You’re in a complex situation.

  • You find it hard to articulate your regulatory strategy to Regulators and Investors.

  • You’re worried about staying on track /are starting to stall…

 

  • You want to fast-track your product (who doesn’t?!) and access additional support from the Regulators but don’t know how to.

 

  • Regulatory is a complete minefield! You don’t know where to start and it makes you *yawn*!

 

  • You don’t have any or the right regulatory expertise and the problem is, you need it fast!

Smarter Options

Here’s how we can help you  

‘Smarter Regulatory Health Check’

A quick reality check to see where you’re currently at

‘Your Smarter Regulatory Roadmap
to Success’

We help you map out your long-term regulatory roadmap
(3-6 months)

‘Making Your Regulatory Success
A Reality’

In-depth assistance at a specific point on your regulatory roadmap
(6-9 months+).

Your Smarter next step is

to book an initial confidential call

to discuss your requirements

and explore whether we are the right people to help you.

Are you smarter?

Smarter companies create coherent, aligned systems and structures.

Smarter companies invest in effective regulatory strategy and relationships.

Smarter companies recruit, nurture and support their staff.

Why work with Smarter?

With over 25 years of experience, we can tell you that the three most important areas to focus on are:

Smarter Strategy

integrating a clear, effective and efficient regulatory strategy in place from the outset;

Smarter Structures

aligning your structures to your ultimate goals to prevent the perils of unpredictable, organic growth;

Smarter Staffing

engaging an agile, resourceful, synergistic team who complement and compliment each other! 

At Smarter, our responsibility is to make sure that your company is set up on the right trajectory maximising chances of success.

Think Smarter

Be Smarter

Act Smarter

How we work

At Smarter, we know that every investment you make needs to work smarter and harder so we take a completely integrated approach.

The more aligned your regulatory strategy, organisational and people are, the more likely the right regulatory strategy will be successfully identified and implemented.

We only take on work that we are well qualified for.

We are well connected across the Life Sciences and we have a wide network of entrepreneurs and experts. If we can’t help you directly, we will introduce you to someone who can.

At Smarter, we understand that time is of the essence. Smarter clients appreciate the fact that we don’t waste time and we tell it like it is.

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

I worked with Ming to develop a better relationship with the Team. Ming was supportive throughout the process. She provided effective coaching tools which helped me to embrace changes in a compassionate way and to reconnect with my heart.  She helped me to realise that to change a difficult situation, you might need to change yourself. I also learned to celebrate myself for every little positive change related to the team relationship or work achievements.

“

Emma, Pharmaceutical Company