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

How to sharpen up FDA medical device submissions and meetings

When medical device companies make an application or submission to the Food and Drug Administration (FDA) a lot of...
News August 05, 2021

Five common questions about taskforces for PPP active substance renewals

With active substance renewals generally happening every ten years in the EU, the regulatory landscape can shift...
News July 30, 2021

TSG strengthens ecotoxicology expertise with the appointment of Jennifer Duncan

TSG welcomes Jennifer Duncan, former Regulator at the UK Pesticide Safety Directorate (now CRD). With 20 years’...
News Press release June 17, 2021

Renewal of authorisation for plant protection products: three ways to help it run smoothly

EU authorisation of an active substance (AS) for PPP applications generally expires after ten years. Well in advance of...
News June 03, 2021

Putting FDA regulatory strategy at the heart of medical device development

Laurie Clarke recently joined TSG Consulting to head up our medical device regulatory practice. Having formerly worked...
News May 27, 2021