Strategic Expertise, Operational Excellence.. . A forward thinking regulatory affairs consultancy with more than 250 cumulative years regulatory experience spanning many therapeutic specialities. We offer the full range of regulatory affairs services from strategic advice in early drug development, to compilation and management of regulatory submissions, and for over 10 years we have helped companies of all sizes and backgrounds maximise the commercial value of their product. We also understand the importance of a clear regulatory strategy and pathway to market which can maximise the value of an asset when negotiating out-licensing agreements, and our proactive collaborative interactions with Regulatory Authorities can improve chances of approval of a product in the optimal time.