Global Drug Development (EU/US) Our services • Due diligence for licensing or investment decision making • Strategic expert input and regulatory advice (CMC, non-clinical, efficacy & safety) • Data assessment, interpretation & positioning • Advice on global development plans (including Integration of value- based payer evidence requirements), Global regulatory strategy and meetings with regulators or payers • Scientific writing of regulatory documents (EU & US): Briefing documents for scientific Advice, Orphan Drug Designation (ODD), Paediatric Investigation Plan (PIP), IMPD and IND, Clinical study reports,The team MAA and NDA/BLA modules, Responses to Agency questions (RTQ) • Scientific writing of Pharmacovigilance/safety documents: RMP, A team of experienced consultants and DSURs, PBRERs scientific writers with significant experience • Operational support and Regulatory project management for ODD, PIP,in the pharmaceutical industry. scientific advice, IMPD, IND, CTAs, CSRs, DSURs… (including Regulatory publishing) Our clients • Development of Client-Customised Operational Platforms From start-ups to global pharma companies When work with us? with punctual, repetitive or permanent need for support. The team can cover any step of the development process, providing consultancy or hands-on operational support. Why work with us? Among our latest missions Our team hold a flexible skill set ranging • Writing clinical modules for submission in EU and US from development strategy to operational • Subject Matter Expert for specific drug/indication execution, as well as leading and managing projects. • Supporting strategy and writing RTQ for centralized procedure They can also work closely with other • Coordination/leadership for EU and US development activities specialists in BlueReg to provide an integrated within a ‘virtual’ company set-up development and regulatory service.