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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

Biopesticides, Plant Growth Regulators, and Biostimulants: 5 questions about the US regulatory framework answered

TSG Consulting recently hosted a panel discussion exploring the process of registering new products in these...
Article April 27, 2021

Analysis of the US FDA’s draft guidance on nitinol-containing medical devices

Senior Regulatory Consultant, Dr. Om Singh, was published in the February 2020 issue of the Journal of Medical Device...
Article February 07, 2020

BPR: 5 steps to correct substance ID

The significance of correct substance identification under the Biocidal Products Regulation (EU) No. 528/2012 (BPR) is...
Article February 04, 2020

REACH: Brexit Q&A

Brexit is a fast-moving subject that will have regulatory and commercial implications for chemical companies with an...
Article January 30, 2019

At the borderline: understanding cosmetic and biocide classification

Products such as antibacterial hand soap or antiseptic mouthwash are commonly used and, while they are generally...
Article October 08, 2018