Regulatory & Quality Compliance
Independent registrar authentication, on-site cleanroom audits, and certified batch lab assays under 100% Bilateral Escrow protection.
How Eximov Authenticates Trade Compliance
Eximov does not rely on forwarded PDF scans. We execute rigorous active verification checks at every critical trade execution milestone.
Registrar Authentication & Legal Vetting
Verification of corporate registration (MCA/CIN), Import-Export Code (IEC), GST tax filings, legal litigation records, and international sanctions/PEP lists.
Execution Deliverables:
- Direct registrar database cross-referencing
- Active legal status & sanctions screening
- Corporate officer KYC identification
On-Site Geo-Tagged Cleanroom Audit
Eximov accredited trade engineers conduct physical on-site inspections of manufacturing shop floors, machinery calibration, and cleanroom air pressure.
Execution Deliverables:
- GPS geo-tagged audit proof & timestamped photos
- ISO Class 7/8 differential pressure monitoring
- Machinery calibration & preventive maintenance logs
Pre-Shipment HPLC Assay & COA Validation
Random lot sampling under ISO 2859-1 (AQL 1.0/2.5) standards with third-party analytical lab testing before any factory gate release authorization.
Execution Deliverables:
- High-Performance Liquid Chromatography (HPLC) assays
- Physicochemical & microbial barrier validation
- Tamper-evident batch serial sealing
Bilateral Escrow & Destination Customs Filing
100% buyer capital protection under neutral escrow custody paired with automated EU ICS2, US AMS, and consular customs pre-declarations.
Execution Deliverables:
- Irrevocable bilateral escrow milestone triggers
- EU ICS2 Release 3 & US AMS pre-filing
- Zero payment release prior to verified POD signoff
Supported Global Regulatory Frameworks
Direct registrar authentication across medical devices, active pharmaceutical ingredients, diagnostic IVDs, and specialty chemicals.
Medical Devices Quality Management System
Medical Equipment & Surgical ToolsThe gold standard QMS ensuring medical devices meet customer and regulatory requirements across design, production, and installation.
Verified Criteria:
- Sterilization validation (EO / Gamma)
- Cleanroom environmental controls (ISO 7 / 8)
- Risk management (ISO 14971)
- Full batch traceability
Good Manufacturing Practice for Pharmaceuticals
Active Ingredients & Generic FormulationsRigorous standards ensuring pharmaceutical formulations and APIs are consistently produced and controlled to international quality benchmarks.
Verified Criteria:
- Blow-Fill-Seal (BFS) sterile lines
- HVAC air handling & pressure differential logs
- Stability data in CTD format
- Water for Injection (WFI) loop testing
European Union Medical Device & IVD Regulations
Class I, IIa, IIb, III & IVD Diagnostic KitsMandatory conformity marking required for commercial distribution and hospital procurement within the European Single Market.
Verified Criteria:
- Notified Body assessment (CE 0123 / 0459)
- Clinical evaluation & post-market surveillance
- Unique Device Identification (UDI)
- Authorized EU Representative (EC REP)
FDA Quality System Regulation & CGMP
Medical Devices, APIs & Finished DosageCompliance with United States Food & Drug Administration regulations for pre-market notification, facility registration, and device listings.
Verified Criteria:
- FDA 510(k) pre-market clearance
- Drug Master File (DMF) submissions
- FDA Establishment Registration & Device Listing
- Annual facility audit readiness
Registration, Evaluation & Authorization of Chemicals
Specialty Chemicals & Pharma SolventsComprehensive European framework ensuring safe chemical handling, environmental compliance, and low impurity thresholds.
Verified Criteria:
- REACH Registration Number validation
- Safety Data Sheet (SDS in EU 2020/878 format)
- Only Representative (OR) coverage
- Substances of Very High Concern (SVHC) screening
WHO Prequalified Medicines & Diagnostics
Global Health Tenders & Public ProcurementEnsures medicines, rapid diagnostic tests, and vaccines meet unified global standards for UN agencies and international donor tenders.
Verified Criteria:
- Priority public health medicines list
- Independent WHO laboratory performance evaluation
- Field stability & temperature logging
- UN tender eligibility
Institutional Quality & Compliance Guarantees
How Eximov removes risk from cross-border healthcare and industrial transactions.
Zero Counterfeit Guarantee
Every quality certificate is validated directly with accredited notifying bodies and government registries before proforma issuance.
100% Bilateral Escrow
Buyer capital is locked in neutral institutional escrow. Funds are never released to the factory without validated inspection reports.
Batch Assay Traceability
Every consignment is accompanied by authenticated Certificate of Analysis (COA), GPS-tagged inspection logs, and cold-chain data.
Ready to Source Under Full Regulatory Assurance?
Submit your procurement specifications today. An Eximov Senior Regulatory & Trade Officer will pre-audit compliance requirements and provide a verified manufacturer proforma within 24 hours.