Regulatory strategy starts before an asset is selected.
Every approved program is intended to have an integrated U.S. plan covering FDA pathway, evidence requirements, CMC, safety, manufacturing responsibility, market access, and lifecycle obligations.
One product plan, multiple disciplines.
- Regulatory strategy: define the U.S. pathway and FDA interaction plan.
- Clinical development: translate the product profile into a feasible evidence plan and milestone structure.
- Medical / safety: own benefit-risk thinking, pharmacovigilance readiness, and scientific governance.
- CMC / technical: ensure process, analytical, formulation, comparability, and control strategy support the regulatory plan.
- HEOR / market access: build payer and health-system evidence needs into planning where relevant.
Major spend follows an approved product case.
External CROs, laboratories, consultants, and development partners may be used, but product accountability is intended to remain with FG. Schedule, evidence quality, supply readiness, safety, and budget are reviewed together.
Screen
Strategic fit, medical rationale, rights, and U.S. potential.
Diligence
Clinical, regulatory, CMC, IP, quality, commercial, and financial review.
Approve
Clear rights, accountability, target product profile, and decision criteria.
Execute
U.S. development plan, partners, supply, evidence, and milestone management.
Continue / Stop
Programs advance only while they continue to clear agreed gates.
Approval alone does not create a commercial product.
Specialty products depend on payer coverage, site of care, specialty pharmacy, IDN and hospital access, physician adoption, supply reliability, and patient-service design. These requirements are intended to influence evidence and launch planning early.
IDNs & Academic Centers
Clinical value, procurement, pathway fit, value evidence, contracting support, and reliable supply.
Infusion & Specialty Channels
Reimbursement clarity, administration efficiency, specialty pharmacy integration, patient support, and field coordination.
Payers & Specialist Networks
HEOR, payer evidence, pricing, utilization management, scientific exchange, and evidence-generation planning.