Precision Medicines Development, Regulatory and Commercialisation
Our team has decades of large pharma and diagnostics experience working with the foremost companies globally. We provide strategic and operational support from drug-diagnostic co-development, regulatory through to launch readiness and market uptake of novel drugs and diagnostics.
Precision Medicines Development
Identification, due diligence and selection of diagnostic companies for partnering
Project management of companion diagnostics co-development programmes and diagnostic studies
Training, monitoring and trouble shooting to ensure consistent, high quality results for clinical diagnostics studies
Technical support for an array of diagnostic methods and technologies
Diagnostic assay development and implementation within clinical studies
Tech transfer to establish global diagnostic testing facilities
Precision Medicine Launch Readiness and Commercialisation
Developing and implementing Global Launch Plans
Co-ordinating and delivering diagnostic projects/initiatives at a global and local/in-country level
Development and implementation of diagnostic strategies to maximise testing for therapy choices
Diagnostics and lab network partner management
Diagnostic training of field force and capability development
Setting up and management of diagnostic studies
Managing quality assurance programmes
Diagnostic market research
Development and delivery of educational campaigns to drive diagnostic testing
Delivering diagnostic advisory boards
Support for health technology assessments
Accessing healthcare professional networks
Precision Medicine Regulatory Services
Regulatory and development advice for biomarkers, companion diagnostics, digital health and other devices across a range of therapy areas and regions
Developing global regulatory strategy for Precision Medicines
Regulatory landscape mapping, assessing regulatory risk, and developing global filing strategies
Ensuring global development plans meet global regulatory requirements
Supporting Regulatory Interactions/Submissions (e.g. FDA- SRD’s, IND’s, PMA’s, EMA – IVDR compliance, PMDA)
Advice on organisational development and outsourcing key regulatory activities
Experience working with