Plan drug and vaccine research around the evidence.

Define the product and research objective

Record the indication, formulation, development stage, prior evidence and whether the product is already marketed. Separate an interventional trial from observational outcomes research. Sponsor-country authorization does not itself permit a trial or product import in Nepal.

Scope the operational work

Use the proposed service areas to identify the functions the study needs, then assess the team and evidence for delivery.

• Protocol-based country and site feasibility
• Ethics and DDA submission coordination where applicable
• Site start-up, training and study communication
• Monitoring, safety-information coordination and essential records
• Close-out reconciliation and handover

Resolve early-phase conditions

Do not assume that every development phase is routinely available in Nepal. NHRC guidance requires particular infrastructure and evidence for Phase I and describes special considerations for Phase II products developed outside Nepal. Discuss the proposed phase directly with NHRC and DDA before making a country commitment.

Prepare for product accountability

Agree the authorized supply route, storage and temperature requirements, dispensing responsibilities, stock records and final reconciliation. Import authorization, customs arrangements and trial permissions need separate confirmation. A website service description is not an importer licence or a pharmacy authorization.