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Come and see us!

This year we will be attending the following upcoming events, book on and come and see us.

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AMR Conference, Basel
3rd - 4th March 2026
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BIOEurope Spring, Lisbon
23rd - 25th March 2026
3. BioTrinity, London Image
BioTrinity, London
14th - 15th April 2026
Insights
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Insights
Novel excipients – Regulatory requirements

A “novel excipient” is an excipient that is not present in an approved medicinal product administered via the same route of administration. The route of administration is important. If, for example, the excipient is only present in approved oral formulations such as a tablets or capsules, but is now included in an injectable product, it will be considered novel.

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Insights
The legal basis of an EU Marketing Authorisation Application

Applications for Marketing Authorisation (MA) in the European Union (EU) are submitted in accordance with the relevant legal basis specified in Directive 2001/83/EC, as amended. The legal basis underpins the regulatory requirement and documentation required. There are six legal bases available. This Insight briefly summarises each one.

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Insights
Due Diligence

Due Diligence is the process in which the value of data is evaluated in the context of a potential investment. The process is therefore multi-disciplinary and covers all aspects of the business or asset under review such as legal, financial, commercial etc, however this Insight focuses on technical due diligence, which in this context is the review of Regulatory, Clinical, Non-Clinical and CMC data associated with a medicinal product.

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Insights
ATC code applications

An Anatomical Therapeutic Classification (ATC) code is a set of 6 letters and numbers issued by the World Health Organisation (WHO) that identifies and classifies an active substance according to its therapeutic use. Prior to submitting an MAA, an ATC code application should be submitted. The procedure is straightforward, and there is no fee, however there are some key considerations.

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Insights
Preparing for an EU MAA—Centralised Procedure

The journey from Phase 3 clinical trials to Marketing Authorisation Application (MAA) is exciting as the final steps in development work are concluded and preparations to launch the product are made. The workload, procedural complexities and importance of careful planning however, should not be underestimated. This Insight summarises the key procedural milestones and considerations for the Centralised Procedure, to ensure each step taken is one closer to success.

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Insights
Brexit – an update from MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) has, on 6th August 2018, published technical guidance for industry on the impact of the UK’s decision to withdraw from the European Union (EU) on the life sciences industry.

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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.”
CTO, clinical stage biopharmaceutical company, Switzerland.
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Global Coverage, Localised Knowledge, Flexible Solutions.

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Switzerland Head Office
Head Office
InsideReg Sarl
rue du Château 4
1350 Orbe
Switzerland
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United Kingdom
Summit House
10 Waterside Court
Albany Street
Newport
NP20 5NT
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Ireland - EU
22 Northumberland Road
Ballsbridge
Dublin 4
Ireland
D04 ED73

Customer Focused, Commercially Aware.

Solution focused

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

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

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

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

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

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.