Lorna provides expertise and mentorship to the European based team as we guide clients through the complex regulatory hurdles from early development through to approval and beyond.

Lorna has been Regulatory Advisor for numerous start up companies including overall strategic development, First in Human support through pre-IND, IND preparation and submission in the US and CTA approvals in the UK and Europe.

She also helps clients develop and implement their Phase II and III plans including advising on early access pathways, paediatric plans, orphan designations and preparation for Agency interactions and submissions.

Lorna has extensive experience of guiding through the complex regulatory process, especially in Europe including the mutual recognition, decentralised and centralised processes. She and her team advise on the strategy to respond to major objections, drive written responses and prepare for Oral Explanations, Scientific Advisory Group meetings and Referrals

Lorna can also review and assess regulatory departments experience and skills vs business objectives.