Regulatory Affairs Consultancy for the pharma, biotech and devices industry
Our team of experts have well over a 100 years of Regulatory Affairs experience between us. We provide regulatory services and support to a wide range of clients from the biggest companies in the world all the way to small biomedical startups. We are agile, experienced, and competitive, making world-class RA available without compromise.
Contact us today to leverage our expertise for your regulatory needs. We offer a no-obligation initial consultation to help you understand our services and to learn how best we can help you deliver.
Supporting Your Regulatory Affairs Needs…
Automating Your Regulatory Intelligence
Stay ahead of the regulatory game Gathering the latest regulatory industry insights to help you keep up-to-date with the…
Developing Winning Regulatory Affairs Strategies
The importance of a great regulatory strategy Every regulatory project requires you to have a good regulatory strategy in…
eCTD Publishing Services
At RegConsult, we understand the intricacies and demands of eCTD submissions in the pharmaceutical and healthcare industries. Our expert…
Regulatory Affairs Outsourcing
Why outsourcing your regulatory affairs is the smart move Competing priorities, a lack of a particular specialism and resource…
NEW: Full Artwork, Labelling and Design Services
To further support all of our clients, we now provide a labelling, artwork and design service for manufacturers of…
Medicinal Product Lifecycle Support
Navigating Regulatory Landscapes Successfully managing a medicinal product’s lifecycle requires more than just compliance; it demands strategic foresight. Our…
What Our Clients Say…
Excellis Health Solutions
As the leading experts in serialisation and traceability, Excellis were supporting a client’s rapid launch of a novel oncology product into the EU via the Centralised Procedure, across all markets to a highly ambitious timeline. In order to provide the client with the full expert support through a single point of contact, we subcontracted with Nik Wells and his RegConsult team to provide additional regulatory knowledge to coordinate and produce submission-ready labelling. 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!
Christoph Krähenbühl
Mr P. Gupta
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.
Paul Gupta
Mariam Aslam
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.
Ms Mariam Aslam
MedicPro London
We benefit massively from RegConsult’s regulatory intelligence services. It’s saved us so much valuable time, not least by removing the need to carry out repeated searches!
Mr M Taylor
Helping You at Every Stage…
As a well-established and trusted regulatory consultancy, we have decades of experience helping companies just like yours