Phil is a CMC Senior Advisor at SFL. Phil can provide strategic and operational advice on CMC and GMP areas for small molecule and biotechnology products.
Phil has over 30 years’ experience with the development and registration of new chemical entity and biological products at pharmaceutical companies and working for the UK Regulatory Agency (MHRA). His experience covers working directly with laboratory staff in the generation of CMC data packages for first-in-man studies and MAA packages, rapporteur assessment of plasma-derived products and monoclonal antibody products for the CHMP as an officially recognised CMC expert and GMP preapproval inspection readiness activities for the successful approval of biologic and sterile product facilities in Japan. He is a specialist in monoclonal antibodies, sterile products and design of experiments.
Phil has authored, reviewed and performed gap analyses on many IMPD, MAA, IND, NDA and BLA documents. He has also directed Project Management, Regulatory Affairs and Quality Departments within pharmaceutical companies, developing high performance teams.
Phil has a Bachelor of Pharmacy from the University of Bath, UK.
SFL Regulatory Affairs & Scientific Communication Ltd.