Honest conversations
We discuss what you want to achieve and where our expertise can help, then agree the work to be done.
About RegConsult
Expertise with a personal commitment.
Experienced regulatory people. Clear conversations. Practical support for the work ahead.
Experienced. Accessible.
A consultancy built around your regulatory needs.
RegConsult was founded by Nik Wells to provide experienced, accessible regulatory support to pharmaceutical and biotechnology businesses.
We bring together relevant specialists around your requirement, combining strategic input with practical delivery. The starting point is a clear understanding of your product, your priorities and the support you need.
Our approach is straightforward: be clear about the scope, involve the right expertise and work closely with the people responsible for moving the programme forward.
Our approach
Clear expectations.
The right balance of expertise and support.
Relevant specialists
We bring experience that fits the regulatory question, rather than treating every programme as the same.
Practical collaboration
We work with your internal team and delivery partners, with clear responsibilities and useful follow-through.
Meet our specialists
Core people behind the advice.
Experience across regulatory strategy, CMC, submissions and regulatory operations.
Nicholas (Nik) Wells
Founder & Managing Director
Nik has worked in regulatory affairs since 1998, with experience as an industry employee, consultant and business owner. He brings practical regulatory knowledge and a personal commitment to understanding the client’s requirement.
Afi Sinclair
Principal Regulatory Consultant
Afi is a regulatory strategy specialist with over 25 years of industrial regulatory experience, supporting the strategic decisions behind development programmes.
Matthew (Matt) Sardo
Senior Regulatory Consultant and Writer
Matt brings over 25 years of regulatory experience, providing strategic and lifecycle support and regulatory writing across our clients’ programmes.
Alex McCulloch
Lead Regulatory CMC Consultant
Alex brings over 40 years of regulatory experience, providing specialist input on chemistry, manufacturing and controls.
Indie Bidiyal
Head of Submissions
Indie brings over 15 years of experience in regulatory operations and submissions, connecting programme requirements with operational delivery.
John Peppiatt
Principal Regulatory Strategy Consultant
John brings over 30 years of regulatory experience in pharmaceuticals and biologicals.
Our clients’ experience
Working together.
In their words.
Regulatory support, described by the people we have worked with.
Swipe or scroll to explore the testimonials.
Discuss your project“Nik and his RegConsult team have provided us with fantastic regulatory support over the last 3 years, as we have continued to grow our UK product portfolio and market presence with their help.”
“RegConsult have been providing us invaluable regulatory advice and strategic support to assist us in our UK regulatory strategies and decisions. We enjoy working with them and appreciate their flexibility, great knowledge and ability to go the extra mile for us. We remain very happy to continue using their services!”
“I had the pleasure of working with RegConsult on a global pharma company’s project requiring regulatory skill, commitment and dedication. They were remarkable in meeting the clients requests and going that extra mile to provide a high quality of work and attention to detail. It would be an honour to work with Nik and his team again.”
“Nik and his regulatory affairs consulting team worked closely with our Medical Writing teams (Pfizer UK) to effectively lead key submission projects that required multi-functional team input.”
“Nik and his team were on hand to help with all aspects, available to turn around the client’s requests rapidly and based on their work, the client’s submission received approval. We couldn’t have asked for much more!”
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Let’s discuss your next regulatory step.
Tell us about your product, your priorities and the support you need. We’ll explore the right scope together.