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Cell banks characterization expectation for microbiome therapeutical products
The last decade has marked the emergence of numerous microbiome treatments investigated in clinical trials. With a broad landscape, spanning…
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FDA Advisory Committee Meeting on Toxicity Risks of AAV Vector-Based Gene Therapy Products: a CMC…
The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) held a meeting on September 2nd and 3rd, 2021, to…
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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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COVID-19 – THE LEARNINGS AND LONG-TERM IMPACT IN CLINICAL STUDY MANAGEMENT IN THE EU/UK
Introduction At the beginning of 2020, COVID-19 pandemic hit the whole world and led to unprecedented measures, including general lockdown…
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2021 Advancing Regulatory Science at FDA: What are the focus areas
The Food and Drug Administration (FDA) conducts research in regulatory science to improve regulatory decision-making by developing new tools and approaches to…
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The implementation of the Clinical Trial Regulation (Regulation (EU) No 536/2014): where do we stand?
While the Regulation (EU) No 536/2014 was adopted back in 2014, its application in the European Union depends on the…
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