ISO 13485 & CE Vetted100% Escrow Trade AssuranceWorldwide Cargo Telemetry
Eximov Global Regulatory & Quality Compliance Framework™

International Healthcare & Industrial Compliance Verification

Eliminate destination customs holds, counterfeit certificates, and regulatory rejections. Eximov authenticates registrar credentials, cleanroom standards, and batch lab assays under 100% Bilateral Escrow.

Eximov Verification Methodology

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.

01
Corporate & Legal Due Diligence

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
02
Physical Facility Audit

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
03
Laboratory & QMS Testing

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
04
Trade Escrow & Customs Pre-Filing

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
Accredited Standards

Supported Global Regulatory Frameworks

Direct registrar authentication across medical devices, active pharmaceutical ingredients, diagnostic IVDs, and specialty chemicals.

ISO 13485ISO 13485:2016

Medical Devices Quality Management System

Medical Equipment & Surgical Tools

The 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
WHO-GMPWHO Technical Report Series

Good Manufacturing Practice for Pharmaceuticals

Active Ingredients & Generic Formulations

Rigorous 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
CE MDREU 2017/745 & 2017/746

European Union Medical Device & IVD Regulations

Class I, IIa, IIb, III & IVD Diagnostic Kits

Mandatory 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)
US FDA21 CFR Part 820 / 211

FDA Quality System Regulation & CGMP

Medical Devices, APIs & Finished Dosage

Compliance 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
EU REACHRegulation (EC) No 1907/2006

Registration, Evaluation & Authorization of Chemicals

Specialty Chemicals & Pharma Solvents

Comprehensive 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-PQWHO Prequalification Programme

WHO Prequalified Medicines & Diagnostics

Global Health Tenders & Public Procurement

Ensures 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
Buyer Protection

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.