Insight/ɪnsʌɪt
'An accurate and deep understanding'
We understand that your journey from discovery to approval can be challenging. This is why we believe that even at proof of concept stage, expert advice can mitigate project risks. Whether you prefer "pay as you go" ad hoc advice, or a full fixed fee project management service, we can help. Wherever you are in your journey, reach out to us and let's explore how we can optimise your chances of regulatory success together.
With so many options, steps and procedural complexities throughout development and during registration, choosing your regulatory strategy can be a daunting task.
We can clarify the options, advise on the best solution, and design and implement the best roadmap for your product.
We support you with
CMC aspects are critical at all stages of product development, from first in humans stage of development to activities such as cost optimisation post marketing.
We can advise and support at all stages of development to ensure a smooth path to approval at each step in your product's journey.
We support you with
We have a team of highly experienced ex-Regulators, ideally placed to advise on Clinical and Non-Clinical strategies at all phases of development.
We support you with
Clinical
Non-Clinical
Swissmedic require local representatives in Switzerland for the purposes of all regulatory activities.
We provide a full service for Pharmaceutical Companies who wish to conduct Clinical Trials or perform Lifecycle Maintenance activities.
We support you with
Our expert publishing team create high quality and technically validated electronic submission packages for submission to EU (EMA, MHRA, National Agencies), the USA (FDA) and Swissmedic.
For Swissmedic CTAs we also support submissions by hard copy or CD through our local office.
We support you with
Access to SME and ODD incentives are limited to companies with a legal establishment in the EU.
With InsideReg offices in Ireland, we are ideally placed to access these incentives on behalf of our clients
We support you with
Laura’s support and guidance was instrumental on bringing our first compound in to the clinic. The high quality initial work has further set us up well to obtain smooth approvals for our subsequent submissions.
Very responsive and helpful
About
InsideReg is a specialist Regulatory consultancy based in Switzerland, the UK and EU, founded to support pharmaceutical companies of all sizes on their journey to approval at every stage of product development
Switzerland
Head Office
InsideReg Sàrl
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
