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Regulatory strategy & scientific advice
Build a clear regulatory route, identify the questions that matter and prepare for productive authority engagement.
Explore this service
Experienced regulatory affairs consultancy
Your Trusted Regulatory Affairs Partner.
Senior expertise and hands-on regulatory affairs support for pharmaceutical and biotechnology companies. From development strategy to submissions and lifecycle management.
From the first question to the next milestoneStrategy. Submission.
Lifecycle.
Lifecycle.
UK, European and US regulatory support
Pharmaceuticals & biotechnology
Senior expertise with practical delivery.
Strategy matters.
As does getting it right.
Regulatory decisions shape your development programme, your submission and your product’s future. You need clear advice from experienced people who can help put it into practice.
RegConsult brings together senior regulatory specialists to support the work that matters to you. A focused project, additional expertise or an ongoing extension of your team.
How we can help
Supporting your decision.
Supporting the delivery.
Explore our core services, then talk to us about the right scope for your programme.
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Regulatory submissions
Coordinate the regulatory work behind a well-prepared submission, from planning and dossier review to authority responses.
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Outsourced regulatory support
Add experienced regulatory capability to your team for a specific project, a capacity gap or an ongoing requirement.
Explore this serviceProduct lifecycle supportExploreRegulatory CMCExploreRegulatory operations & eCTDExploreLabelling & artworkExplore
Need a combination of services? We can bring the relevant expertise together around your project.
View all servicesWho we work with
Expert support that fits
your organisation.
Emerging biotech
Shape your regulatory route, assess the next development decision and bring specialist experience into a growing team.
Support for emerging companiesEstablished pharma
Add experienced capacity for submissions, lifecycle activities and specialist workstreams across your portfolio.
Support for established teamsDevelopment partners
Bring regulatory expertise into a wider delivery team, with clear interfaces and a coordinated workstream.
Support for delivery partnersA straightforward way to work
Clear thinking.
Close collaboration.
We take time to understand your requirement, define the work and involve the people best placed to help.
01 / UNDERSTAND
Your product. Your priorities.
We start with the regulatory question, the evidence available and what your business needs to achieve.
02 / PLAN
A clear scope and a practical plan.
We agree the work, the relevant expertise and the responsibilities needed to move it forward.
03 / DELIVER
Experienced people, hands-on support.
We work with your team on the agreed activities, keeping decisions, dependencies and next steps visible.
Experience in practice
Excellis Health Solutions · EU oncology programme
Regulatory labelling support within a wider launch team.
Working with Excellis, RegConsult coordinated and produced submission-ready labelling for a novel oncology product’s EU programme.
Read the case study“We couldn’t have asked for much more!”
People behind the advice
Experienced specialists.
Personal commitment.
RegConsult was founded by Nik Wells, who continues to lead the business and has worked in regulatory affairs since 1998. Our team brings specialist experience in strategy, CMC, submissions and regulatory operations.
Meet the team
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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Perspectives & practical thinking
Start with a better question.
Before the next milestone: five questions for your regulatory plan
A focused starting point for a more useful conversation about your programme.
Read the articleSubmission readiness starts before publishing
Why ownership, dependencies and document readiness deserve attention early.
Read the articleMaking outsourced support work as part of your team
Define the work, the interfaces and the handover before adding capacity.
Read the articleLet’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.