Program oversight and site management
Cross-functional oversight of sites, CRAs and vendors, with qualification, activation and risk-based monitoring.
Regulatory agency navigation
Pathway assessment, submission sequencing, risk mitigation, import licensing and inspection support.
Logistics, import and cold chain
Importer of record, permits, customs clearance, duties, temperature control and shipment tracking.
Laboratory and sample operations
Central and local lab coordination, chain of custody, biosample export to the US and Europe.
Quality, safety and compliance
ICH-GCP quality systems, CAPA, quality risk management, TMF oversight, inspection readiness and pharmacovigilance.
Site and investigator payments
In-country payments, currency handling, withholding tax and transparent sponsor reconciliation.
Medical affairs and community engagement
Advisory boards, investigator meetings, HCP education, patient roundtables, adapted materials and medical writing.
Travel readiness and cultural navigation
Site visit support, visa processing, in-country transport, lodging and guidance on local norms.








