The Regulatory Affairs Company is the strategic component of the TCTC Group’s international business. The group was originally formed as The Clinical Trial Company in 2002. Its Directors are Ewan Campbell and Kerri Leeming, both previously senior level personnel with independent biotechs and pharmas.
In common with its sister companies, our corporate structure facilitates optimum commercial efficiency in helping bring clients’ products to market.
Central to this process is the Regulatory Affairs function which develops the route to market. The Regulatory Affairs Company places great emphasis on planning clients’ product road maps to suit their individual product characteristics. At the heart of the Regulatory Affairs offering is the marketing authorisation, the supreme goal. All planning is focused on getting products to market at the earliest opportunity.
The Regulatory Affairs Company offers the advantage of comprehensive client-side experience to companies seeking to challenge over-cautious approval strategies which are sometimes an indicator of inadequate broad spectrum Regulatory Affairs experience.