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Latest Blog posts
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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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Summary of FDA Advisory Committee on COVID-19 Vaccines (Oct 22)
On Oct. 22nd, the Vaccines and Related Biological Products Advisory Committee from FDA held a nine-hour virtual meeting (Advisory Committee Meeting) to…
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What are the Need-to-Know incentives associated with an Orphan Drug Designation (ODD)?
With a low prevalence, rare diseases affect six to eight percent of the population worldwide and therefore represent a global…
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Tips to Select the Right Notified Body
In Europe, the review and approval of medicinal products involve Medicinal Competent Authorities from A to Z, the review and…
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New FDA Guidance on Multiple Function Device Products & Its Impact on Software as A…
While the original Apple Watch was a genuine consumer product with fitness tracking and health-oriented capabilities, the adjunct of the…
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New Guidance on Clinical Evaluation of Medical Device Software
The Medical Device Coordination Group (MDCG) recently published a new guidance entitled “Guidance on Clinical Evaluation (MDR) / Performance Evaluation…
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Advice on Non-clinical and Clinical Development for ATMPs from an Ex-CAT member
Gene Therapies and Cell-based products, referred to as Regenerative Medicine Advanced Therapy (RMAT) in the USA and as Advanced Therapy Medicinal…
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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…
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