A proven regulatory consultancy backed by 20 years experience.

Wherever you are on your regulatory journey, from discovery to launch, InsideReg will guide you to your destination.

We are a specialist Regulatory Affairs Consultancy supporting companies of all sizes as they navigate research, development and commercialisation of medicinal products.

Our expert teams combine decades of industry and regulatory authority experience with agile, innovative, solution focused approaches to successfully guide products through all development phases, from concept to launch.

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Integrated regulatory intelligence and consultancy backed by a team of ex-assessors.

We understand the challenges of the journey from discovery to launch.

This is why we believe that even at proof-of-concept stage, expert advice can mitigate risks, thus streamlining the path to regulatory approval.

All our subject matter experts (SMEs) bring decades of experience to our team.

Many are ex-regulatory authority assessors, putting us in the unique position of being able to share key insights into the workings of the regulatory authorities, their mindsets and likely approaches to regulatory, clinical, non-clinical and CMC solutions.

Our Service Offering

Test tubes showing close up views of cells under a microscope Image

Non-Clinical

Our non-clinical experts have extensive experience in the data requirements of the various stages of development, enabling them to advise on strategic and operational objectives.

CMC

CMC aspects are critical at all stages of product development, from first in human trials through to post marketing cost optimisation activities. Whether you are developing a small molecule, a biological or an ATMP, our experts can advise you on every aspect of CMC development.

Clinical

Advancing novel therapies requires a combination of extensive clinical development, regulatory expertise and operational excellence to ensure success and to navigate potential obstacles in a right first-time manner. Our clinical experts will support you throughout: from selecting the target indication, through to clinical trial design, protocol authoring and study reporting.

Regulatory

With so many options, steps and procedural complexities throughout development and registration, selecting the best regulatory strategy can be daunting. We will clarify the options, find the best solution and provide support at every milestone.

Global Coverage, Localised Knowledge, Flexible Solutions.

Switzerland Head Office

Head Office
InsideReg Sarl
rue du Château 4
1350 Orbe
Switzerland

United Kingdom

Summit House
10 Waterside Court
Albany Street
Newport
NP20 5NT

Ireland - EU

22 Northumberland Road
Ballsbridge
Dublin 4
Ireland
D04 ED73

Customer Focused, Commercially Aware.

Solution focused

We believe that there is always a solution and navigating challenges with ease is our “every day”. With an expert team and clear strategic guidance, we make the pathway to success a series of achievable milestones and accomplishments.

Commercially aware

We know that investment and funding is hard won. Our focus is on maximising the value in everything we do, offering flexible pricing models, so that you can select what works best for you and your project.

Deeply knowledgeable

Our Experts have an average of 20 years’ experience in their fields. This expertise and knowledge means that our clients benefit from integrated strategies built from many years of previous successes.

Insightful

Many of our Experts are ex-Assessors. This uniquely positions us to share our knowledge and key insights into the workings and mindsets of the Regulatory Authorities, delivering clarity and foresight, and always remaining a step ahead.

Agile

We understand that time is precious. Our close-knit teams are ideally placed to navigate changing environments and priorities, rapidly repositioning data and objectives as new information emerges.

Collaborative

We focus on creating teams bespoke to each project, optimising alignment between Expert and Client. This personal approach means that we blend seamlessly into your team, working alongside each of you to support your company objectives.

Testimonials

What our
customers
are saying...

“We have worked with InsideReg for a while now, they are always very flexible to support our regulatory team as needed. We really appreciate their collaborative approach.”

Executive VP, medium-sized CRO, UK.

“Very responsive and helpful.”

Regulatory Director, large biotech, South Korea.

“InsideReg supported us to understand the regulatory challenges of our product. That was key to get credibility in front of investors.”

CEO, Start-up/pre-clinical stage biotech, Switzerland.

“Invaluable! A trusted partner, whom we often rely upon for high quality regulatory expertise, at the strategic and operational level. InsideReg are extremely flexible and responsive.”

VP, CRO, UK.

“InsideReg’s support and guidance was instrumental to bringing our first compound into the clinic. The high-quality initial work has further set us up well to obtain smooth approvals for our subsequent submission.”

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A proven regulatory consultancy backed by 20 years experience.