Bonella Ramsay

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.