Education

- BSc Chemistry/Biology: University of Surrey (UK)

- PhD Immunology/Chemical Pathology: University of London (UK)

Professional Experience

- Therapeutic Antibodies, Inc (UK) / 7.5 Years

Senior Researcher. Responsibilities included preclinical and clinical research, drug development, manufacturing plans, and quality controls of a number of drug candidates, including biologics.

- PMP Consulting Co., Ltd (Japan) / 10 Years

Technical and Regulatory Consultant. Duties included preparation, review and editing of clients CTD documents, design clinical and CMC strategies for effective drug development, regulatory registration and management of APIs, excipients, and packaging materials Master Files (MFs).

- PMP Consulting Co., Lt (Japan) / 19 Years (current)

CEO & Principal Consultant. Activities include:

• Act as CMC Quality Expert before regulatory authorities on behalf of clients

• Develop and provide professional training and development at client’s premises

• Deliver customized seminars at client’s premises and at international pharma conventions. My latest seminar was at the CPHI Japan 2024 “Regulatory Considerations in Drug Formulation: Specifications and Impurities

• Conduct regulatory compliance internal audits at client’s premises.