Skip to content
Book a call
Call Us
+41 21 802 18 77
Message Us
Please enable JavaScript in your browser to complete this form.
GDPR Agreement
Book a Call

To book a call with founder, Laura Millichamp, and discuss your project please click the button below and select a time and date that works for you.

View available slots

Contact us to discuss how we can support you on your regulatory journey

Need support on your journey to regulatory success?

We would be delighted to hear about your product.

Call, e-mail or make an appointment for a free and confidential discussion to understand how we can help or complete the form below.

Call Us
Email
Post

InsideReg Sàrl,
Rue du Château 4,
1350 Orbe,
Switzerland

Book a call
two people walking up a mountain though the snow Image
Bonds Image
World Image

Global Coverage, Localised Knowledge, Flexible Solutions.

Switzerland Office Office Icon
Switzerland Head Office
Head Office
InsideReg Sarl
rue du Château 4
1350 Orbe
Switzerland
UK Office Office Icon
United Kingdom
Summit House
10 Waterside Court
Albany Street
Newport
NP20 5NT
Ireland Office Office Icon
Ireland - EU
22 Northumberland Road
Ballsbridge
Dublin 4
Ireland
D04 ED73
Get in touch
Please enable JavaScript in your browser to complete this form.
Name
GDPR Agreement
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.

Read More
Finger print under microscope Image
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.

Read More
cells under a microscope Image
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.

Read More
Hexagonal structure under lights Image
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.

Read More

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.
Insights
Image
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.

Read Insights
Image
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.

Read Insights
Image
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.

Read Insights
Image
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.

Read Insights
Image
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.

Read Insights
Image
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.

Read Insights