Latest insights

Medical device 510(k) premarket notifications: sometimes slow and steady wins the race

As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major...

Medical device 510(k) premarket notifications: sometimes slow and steady wins the race

As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major...

News archive

Insight 7: Substantiating biocidal product efficacy

Samantha Walker, Senior Biocides Consultant at AG8大厅登录 Consulting looks at how to identify and rectify efficacy data gaps...
News December 14, 2021

Insight 5: Household biocides and hand sanitizers – how to walk the line between consumer expectations and regulatory demands

Hand and household hygiene have taken on new significance since COVID-19 came into our lives. At the start of the...
News December 10, 2021

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