Welcome to M2D Global Life Sciences (M2D). We are a specialty consulting firm where clients achieve sustained business outcomes resulting from work excellence, integrity, an exceptional communication style, strong leadership and a rich understanding of client business at both strategic and tactical levels. M2D provides consulting services, program management and organizational transformation expertise across a variety of functional areas including pharmacovigilance (PV), quality and compliance, product quality complaints, and medical affairs. We have a passion for helping emerging and established biopharma organizations address a multitude of business challenges including full Pharmacovigilance (PV) functional builds and transformations. This includes the setup and management of pharmacovigilance systems, governance structure, supporting SOPs, quality and compliance enhancements, process and re-engineering improvements within clinical and postmarketing-stage biotech and pharmaceutical environments. The results yield a highly efficient operational and inspection-ready PV function. M2D is located near Yale University at the midpoint between the pharma hub of NY/NJ and the biotech capital of Cambridge, MA, and we easily service clients around the globe.

Strategic Mapping and Product Positioning Web Design & Optimization Patient Relationship Marketing Budget/P&L Management Competitive Intelligence Scientific Exchange/Publication Planning Strategic Business Process Optimization & Transformation Pharmacovigilance Global Regulatory Expertise PSMF management Quality & Compliance Strategic Business Process Optimization & Transformation Web Design & Optimization Budget/P&L Management Quality & Compliance Pharmacovigilance (PV) Functional Builds Drug Safety and Pharmacovigilance System Setup Pharmacovigilance Transformations Establish PV Quality System Pre-marketing Clinical Stage PV Setup PV Operational and Inspection Preparedness PV Inspection Readiness PV Operations and Vendor Management PV Business Process Off-shoring/Outsourcing (BPO) PV Department Resource Planning PV Diagnostic Assessments and Gap Remediation