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Ask the experts: Will you be ready for the new IVD regulation?
The major switch from IVD directive to IVD regulation is happening next year on the 26th May 2022. Notified Bodies (NB) and IVD legal manufacturers are getting ready for this…
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Non-traditional US Regulatory Programs for Drug and Medical Device Development
Introduction The Food and Drug Administration (FDA) offers several routine meeting types including Types A, B, B (End of Phase (EOP)), and C as outlined in Formal Meetings…
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Social Security Finance Bill 2021 in France: Reform on early access to health technologies What…
The PLFSS 2021 law was voted but all decrees are not yet published. Ongoing discussions with the CEPS (Pricing Committee)…
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IVD Directive to IVD Regulation (EU 2017/746) Transition – 8 Months Remaining
IVD Regulation Postponement Today 14th October 2021 the European Commission has issued a Question and Answers press release on the…
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Key Points in the CTR Transition of Clinical Trials
Are you an innovator with a product undergoing clinical trial? This article covers all you need to know about the…
Case study
How Our Proactive and Reactive Team Improves the Client Experience
Want to have the best client experience during product development? We achieve it through a proactive and reactive team that…
Case study
Key CMC Challenges for Innovative Healthcare Products
Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product…
Case study
Early Asset Strategic Positioning Enhances Product Development Plan
A French based research company was looking for a proper guidance on positioning their main asset and estimate the market…
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Critical Materials considerations for Cell and Gene therapy product development – Part 2
In Part 1 of this blog, we covered the definitions of Starting Materials, Raw Materials, and Ancillary Materials. In Part…
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Critical Materials considerations for Cell and Gene therapy product development – Part 1
Raw and starting materials are an essential part of cell-based and gene therapy products (CGT). Frequently, the development of Cell…
webinar
Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company
Have you wondered about the role of patient engagement in healthcare product development? Currently, there is a huge emphasis on…
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FDA Meeting Series: How, When and What – EOP Meetings
End-of-phase (EOP) meetings occur when development has reached the end of a particular phase and is ready to move to…
