Bonella Ramsay
Counsel Global Regulatory
Languages
English
-
Overview
-
Experience
-
Credentials
-
Insights and events
Bonella Ramsay is a dedicated life science regulatory law, IP and technology lawyer. She advised life sciences (biopharma and med tech) companies on a wide range of regulatory matters including clinical trial requirements, early access schemes, marketing authorisations, CE marking, product labelling, promotional and non-promotional activities, Brexit issues and regulatory compliance generally.
Bonella also advises on international commercial transactions in the life sciences/med-tech sectors, including complex, strategic partnering, clinical/commercial agreements spanning the life cycle of medicinal products/medical devices; from tech, transfer and licensing, research and clinical trial agreements, outsourcing of regulated functions/services, supply chain arrangements, market access, quality and pharmacovigilance agreements and public procurement/ tenders.
Prior to joining Hogan Lovells, Bonella was a partner at another major international law firm where she co-chaired the firm's Global Life Sciences Sector for 10+ years.
Representative experience
Advising various multinational pharmaceutical companies on the regulatory requirements relating to marketing authorisations and manufacturing, import and wholesale dealer licences.
Advising widely on the impact of Brexit on pharma and medical device companies and transitional arrangements.
Advising pharma companies on regulatory strategy for orphan drug applications, orphan drug regulations and intervening in the General Court where application is refused.
Advising on the regulatory aspects of the acquisition by AmerisourceBergen of the Alliance Health wholesale distribution and logistics group in Europe and the Middle East.
Leading pharma regulatory and code compliance reviews pharma companies and their European affiliates.
Advising a pharmaceutical company on the use of AI in product development.
Advising on the introduction of genomic services as a standard care within the NHS for rare diseases and cancer and the provision of genomic testing laboratory services.
Advising on multi-jurisdictional clinical trials and investigator led studies, ICFs, clinical data transparency, GCP and data privacy breaches, and secondary use of clinical data.
Providing guidance on use of new technologies and security tools to modernize clinical trial methodologies and clinical development services agreements.
Advising a global biopharma company on R&D spin-outs, collaborations, outsourcings and services arrangements, including IMI funded stem cell bank project and co-promotion partnering deals.
Advising on International R&D, manufacturing and supply collaborations and contracts for a wide variety of medicines and medical devices.
Credentials
- Diploma in Law, City, University of London, Diploma, 1988
- B.A. Philosophy, University of Warwick, 2:1, 1986
- Solicitor, England and Wales