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Unlocking the EMA Meetings: the Process and How to Prepare Adequately
Clear strategy, compelling argument and well-rehearsed preparation are all key to having a successful EMA meeting, no matter if it is a Scientific Advice meeting or a CHMP meeting. In…
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presentation
Navigate the maze of MDR for Medical Device Software
This presentation is aimed at helping developers navigate the development and regulation maze of MDR for medical device software. Some…
publication
Recent Revisions to Legislation Impacting the Pharmaceutical Industry in Switzerland
With the objective of harmonizing pharmaceutical regulatory practices and legislation with Europe, the Swiss Medicines Agency (Swissmedic) recently conducted an…
presentation
Overview of EU Regulatory Landscape for Regenerative Medicines
Regenerative medicines, part of the so-called Advanced Therapy Medicinal Products (ATMPs) in Europe, are cell-based medicinal products aiming at replacing…
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blog
Expectations from Regulatory Agencies on Nitrosamine Impurities
On Friday, 27th March 2020 the, European medicines regulatory network extended the deadline to complete an initial risk evaluation for…
webinar
Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
presentation
Deep Dive into FDA’s Expedited Programs for Drug Development
If you are developing products for serious and life-threatening illnesses with unmet medical needs, there are several mechanisms offered by…
blog
How to Successfully Manage The Challenges of Developing an ATMP
ATMPs (Advanced Therapy Medicinal Product), covering cell and gene therapy products, have a huge therapeutic potential to treat serious diseases.…
Case study
An Integrated Regulatory and Market Access Solution for a Successful MAA
A US-based biotech looked for a trusted regulatory partner to: 1) Build and execute an EU regulatory strategy and roadmap…
Case study
Multidisciplinary Support for a Successful ODD Application
A US biopharmaceutical client had to withdraw their ODD application during the COMP’s review procedure, due to the lack of…
publication
A Regulatory Landscape Shift for In Silico Clinical Trials
Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to…
Case study
Creating a Regulatory Strategy for Software as Medical Device
A mobile diabetes software app for patients with diabetes to assist them in the management of their disease by monitoring…
