Founder of RApport, Lorna has more than 30 years of experience in Regulatory Affairs, both in industry, having worked for Rorer Health Care, Astra and Proctor and Gamble and for the last 20 years as a consultant.
Lorna is a strategic thinker, who has advised on product development in numerous therapeutic areas, driving them through European regulatory processes; centralised, decentralised and mutual recognition. She has a special interest in development strategies including the preparation, planning and attendance of Scientific Advice meetings; EMA, FDA and EU national.
Lorna advises on licensing and acquisition activities, conducts regulatory department review and development planning. She is also an experienced regulatory trainer.
Kelsey has over 12 years of regulatory experience, having worked in a UK affiliate role across Europe and more recently as a global regulatory lead in GSK Consumer Healthcare. She has worked on both prescription and non-prescription (OTC) products managing the product lifecycle from development through to MAA submission.
A qualified pharmacist, Kelsey has worked directly with patients within the National Health Service and Community Pharmacies in the UK. This broad background in pharmaceuticals enables Kelsey to work across a wide range of therapeutic areas and to handle all aspects of the regulatory dossier.
Ifty Saiyed is an experienced global regulatory consultant with over 17 years' experience within multinational pharmaceutical companies, contract research organisations and consultancy covering a wide range of countries and projects.
Ifty's particular strengths include strategic clinical and regulatory issues within biologicals, as well as building capabilities in others, effective interaction within project teams and external organisations, leading work streams, technical writing and carrying out due diligence projects.
Ifty also has a keen interest in regulatory intelligence and policy, which enables us to move projects forward with confidence.
Amanda has over 10 years of experience in regulatory affairs in industry with Novartis but predominantly in the CRO sector. She has worked within the clinical departments of two global CROs, supporting the company’s clinical business. More recently she has worked as a specialist regulatory consultant, providing a wide range of services including regulatory strategy and advice, preparation of regulatory submissions, management of clinical trial applications and user testing of Patient Information Leaflets.
Amanda graduated from the University of Bath with a first class degree in Pharmacy and worked as a pharmacist within the UK National Health Service. Amanda has a strong eye for detail and her practical and technical skills enable her to provide excellent support to our clients.
Gail is a medical writing consultant with over 25 years of experience in pharmaceutical development and over 15 years of experience in the preparation and management of clinical regulatory documentation for both pharmaceutical companies and CROs.
In a prior role as Director of Medical Writing at Ipsen, Gail was responsible for global medical writing and publishing activities, ensuring submission ready regulatory documentation across drug development and medical affairs, and acting as the clinical submission lead on key projects. This strategic role also involved contributing to technical assessments of proposed development plans and extensive people management.
After graduating from Humberside in Business Information Systems, Liz was initially appointed as a Computer Operator at IBM in Portsmouth. This was the start of a 12 year role with IBM, culminating in the management of large technical delivery teams.
Taking a career break to raise four children, Liz took on a variety of voluntary roles including acting treasurer for a local charity and Clerk to Governors for Hampshire County Council.
Her varied responsibilities in life have meant that she handles the challenges that business support brings her with efficiency and genuine enjoyment.
We have built strong relationships with a number of partner companies over many years. These partnerships are extremely important to us, allowing us to provide a fully comprehensive service to our clients.