Sourcing, supply, and logistics — engineered for clinical research.
Ten connected capabilities working as one supply chain — from Tier-1 procurement, BA/BE and API supply through dossier, export and analytical services to last-mile clinical delivery under validated cold-chain.
RLD & Comparator Drug Sourcing
Direct procurement of Reference Listed Drugs and comparator products from authorized channels in the US, EU, UK, Japan, and other Tier-1 markets. Full pedigree, invoicing, and manufacturer documentation supplied on every order.
- US / EU / UK / JP market access
- Full COA and pedigree documentation
- Long remaining shelf-life negotiated
- Single-lot bulk procurement
Clinical Trial Supply
End-to-end supply management for Phase I–IV multicenter studies. Sourcing, blinded labeling, kitting, secondary packaging, storage, and site distribution — coordinated globally with QP release where required.
- Blinded / open-label kits
- Investigator brochure alignment
- QP-release coordination
- Site-level distribution management
Cold-Chain & Specialty Logistics
GDP-validated temperature-controlled shipping across ambient, 2–8°C, -20°C, and -80°C ranges. Real-time GPS and thermal monitoring, IATA-compliant dry ice / gel-pack packaging, and end-to-end excursion reporting.
- 2–8°C, -20°C, -80°C validated lanes
- Real-time GPS + thermal monitoring
- IATA dangerous goods handling
- Excursion & CAPA reporting
Regulatory & Import Support
Import/export licensing, narcotics permits, customs clearance, and complete regulatory documentation support for emerging and regulated markets. Local partners in-country for expedited release.
- Import & export licensing
- Controlled substance handling
- Customs & broker coordination
- Emerging market compliance
BA/BE & Comparative Dissolution Support
Bioavailability and bioequivalence programme support — comparator identification, single-lot procurement matched to study design, and study material management with documentation acceptable to demanding reviewers.
- Comparator batch matching
- Dissolution study material supply
- Study-aligned shelf-life
- Full CoA / batch records
API Sourcing & Market Development
Strategic access to active pharmaceutical ingredients from GMP-certified, DMF-registered manufacturers, paired with market entry intelligence for new territories.
- DMF-registered manufacturers
- Audit & qualification support
- Commercial-scale contracts
- Market entry intelligence
Dossier & DMF Support
Structured CTD/eCTD documentation services to accelerate drug registration across global markets, including gap assessment, module compilation, and submission readiness review.
- CTD / eCTD compilation
- DMF coordination
- Gap assessment & remediation
- Submission readiness review
Export & Tender Support
Export facilitation, international tender qualification, and market access advisory — from pre-qualification documentation to shipment execution and post-award supply continuity.
- Tender pre-qualification
- Export documentation
- Market access advisory
- Supply continuity planning
Columns, Impurities & Reference Standards
HPLC/UPLC columns, impurity reference standards, and certified working standards for precision QC operations — sourced with certificates and traceable lot data.
- HPLC / UPLC columns
- Impurity reference standards
- Certified working standards
- Traceable lot certificates
Pharmacovigilance
Systematic adverse event monitoring, ICSR and PSUR preparation, and ICH E2A / E2B (R3) aligned regulatory reporting to protect patients and safeguard product market standing.
- ICSR case processing
- PSUR / PBRER preparation
- Signal detection support
- ICH E2A / E2B (R3) alignment