Antony Appleyard
PhD CChem FRSC
Antony is a CMC, drug development and regulatory consultant. He has a diverse background in drug research and development with experience in assisting small or virtual (bio)pharma companies towards, into and through clinical studies. Development support is provided during preclinical and clinical development, including registration ready activities for MAA, NDA and BLA.
Advice is provided to clients developing peptides, semi-synthetic natural products, conventional small molecules, ATMPs, antibody-drug conjugates, biosimilars, biobetters, vaccines, therapeutic proteins, monoclonal antibodies and novel biologics.
| Name |
Antony Appleyard |
|---|---|
| Qualifications |
PhD CChem FRSC |
| Area(s) of expertise |
Manufacturing Regulation, Health and Safety Strategy and Policy |
| Services offered |
Drug development and regulatory consultancy service for pharmaceutical and biopharmaceutical clients Planning and writing of regulatory documentation, submission of CTAs (IMPD, IND, IB, response to questions etc.) Planning and writing of briefing documents and provision of support for scientific advice meetings with competent national authorities MAA/NDA/BLA Technical transfer API and drug products New chemical entities, pharmaceuticals, biologics, gene and cell therapy Placing and management of CMO/CRO outsourcing projects (CMC and non-clinical) Interim drug development director/VP covering CMC, non-clinical, clinical and regulatory activities CMC due diligence, gap analysis and development plans Guided companies in the collation of credible CMC packages for divestiture |
| Markets served |
New chemical entities Pharmaceuticals Biologics Gene and cell therapy ATMPs |
| Geographic regions served |
EU and US regulatory coverage with clients worldwide |
| Online |