My Services

• Scalable, fractional legal support and consultancy.
• Commercial contracts and transactional legal support.
• Regulatory and compliance support.
• Global data privacy support, including external Data Protection Officer services.

Drafting and negotiating agreements (including templates with playbooks as needed) and practical legal advice. Examples include:

• Ancillary Services (eg Laboratory, Pharmacy, Radiology);
• Bespoke Agreements (partnership, collaborations, non-circumvention etc);
• Confidentiality;
• Consultancy (general and HCP);
• Employment matters;
• In & Out Licensing;
• Intercompany relationships;
• Master Services Agreements;
• Material Transfers;
• Pharmacovigilance;
• Quality;
• SaaS/PaaS/AIaaS; and
• Standard Terms & Conditions.

General and life-sciences specific data privacy advice and transactional support (Data Processing Agreements and data flows) and External Data Protection Officer Services.

Project-based support, including:

• ­Deep dives into legacy practices and corrective actions (through to implementation and training);
• Creation of global data privacy programmes, including mapping, policies, procedures, training,  ROPAs  - data processing activity assessments (lawful basis, LIA, DPIA, TRA etc) and Data Processing Agreement templates; and
• Clinical Trial Data Protection specific documents, including Patient Information Sheet / Informed Consent and Protocol language.

Wide scope of set-up and transactional support, spanning manufacturing and supply, product development services (with IP focus), distribution and licensing (in and out), including:

• ­Development of bespoke agreement templates for global use;
• Evaluation and negotiation of individual agreements; and
• Practical Health & Safety & Environmental matters including investigations.

Practical global compliance advice and support, including:  

• ­IFPMA, EFPIA and National Code Compliance regulatory advice, workflows, contractual template suites and contractual support covering permitted Healthcare Recipient interactions and annual transparency reporting; 
• Development and implementation of compliance programmes for clients who are launching and/or have recently launched licensed products in the UK and EU markets, including training; 
• ­Review and updates of legacy compliance programmes and corrective action plans;
• Transparency and market value assessment advice and reporting architecture utilising SharePoint; and 
• Anti-bribery & corruption and due diligence advice and risk-based solutions.

From pre-clinical through to global late-phase clinical development, including:

• Bespoke Collaboration and R&D Agreement drafting and negotiations with IP focus, both academic and commercial, including ancillaries such as Material Transfer Agreements; 
• ­Global clinical trial and ancillary agreement template suites (including fallbacks), negotiations and dissemination; 
• ­Outsourcing/Vendor Management covering RFPs, CRO Master Service Agreement development and negotiations and ancillaries; and 
• ­Collaborative development projects (inc. NHS) of Apps and SaaS platforms.

Design and implementation of scalable SharePoint architectures, including self-service legal portal sites and contract management systems, leveraging SharePoint to streamline legal and non-legal operations for organisations with limited in-house legal resources or smaller budgets. Architectures are designed to:

• Enhance privacy and confidentiality compliance;
• Allow clear oversight;
• Enable cross-functional collaboration;
• Support risk mitigation; and 
• Be simple to use.