In the unfortunate event that you are informed by the FCA that they are minded to instruct a Skilled Person's review (s166), or should your firm be issued with a Requirement Notice, there is still plenty of opportunity for you to influence the fate of the review.
Our team is led by experienced regulatory partners and lawyers who have been Skilled Persons themselves. Our senior delivery and oversight team have experience in project managing Skilled Persons reviews and providing subject matter expertise. Our delivery teams are all comprised of individuals who have either been involved in contributing towards s166 reviews, or have deep experience of working for the regulator.
How we can help you
Our service has two main objectives:
Avert & minimise the review: To present any and all reasonable regulatory based arguments to convince the FCA not to proceed with the review and demonstrate that a favourable outcome can be achieved through other means in a manner congruent with FCA's objectives.
Manage & steer: Reduce scope, focus, impact and cost to the business by proactively managing the review from the firm's perspective.
Once we have had an orientation and strategy session with your business, we will work out a bespoke strategy for your firm, which is agreed with you, as your mine line of defence.
For more information on our Independent Review service, please download our brochure
A crucial element of clinical research and key to advancing innovative medicine; public consultation with the HRA and NI Department of Health has resulted in the most significant overhaul of clinical trial regulation in two decades.