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Six steps to obtaining 510(k) premarket clearance for medical devices

What’s the best way to go about obtaining FDA authorization to market a medical device? This is the million-dollar...
News December 10, 2021

Insight 4: Identifying data gaps for US and EU approval of new agricultural active substance

A global chemical products manufacturer needed specialist guidance on data development in order to bring a new...
News December 09, 2021

Insight 3: How manufacturers of biopesticides for agricultural applications can accelerate time to market by taking a global perspective on regulations

Manufacturers of biopesticides for agricultural applications can accelerate time to market by taking a global...
News December 08, 2021

Insight 2: Cross-sector, cross-discipline expertise underpins effective and efficient product innovation

As highlighted in yesterday’s insight, The importance of shaping regulatory strategy at the start of the product...
News December 07, 2021

An overview of FDA’s premarket regulation of medical devices

FDA’s legal and regulatory framework The definition of a medical device FDA’s risk-based classification of a device...
Article December 07, 2021