Insight 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 Continue Reading
'An accurate and deep understanding'
Our Insights are designed to give you a high level overview of key regulatory activities, which together with our Inside perspective, bring you a step closer to your regulatory success.
Brexit – an update from MHRA
InsightThe 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 Continue Reading
Preparing for an EU MAA
Insight 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 Continue Reading
ATC Code Applications
Insight 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 Continue Reading
Clinical stage biopharmaceutical company / CTO
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.
Large Biotech / Regulatory Director
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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
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