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Securing the medicine supply chain

We support biotech, CDMOs, pharma companies, and agencies to strengthen every critical link, from distribution to quality governance.

Our DRUS approach combines regulatory expertise, operational leadership, and targeted automation to reduce risk, speed up decisions, and improve supply continuity.

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DRUS approach

4 pillars to secure the supply chain

A structured consulting offer built around availability, resilience, harmonization, and sovereignty.

D

Distribution & Availability

Operational control of the physical supply chain.

R

Resilience & Shortage

Supply continuity and crisis management.

U

Urgency & Harmonization

Regulatory alignment and cross-border flows.

S

Security & Sovereignty

Quality governance, integrity, and sovereignty.

D

Distribution & Availability

Operational control of the physical supply chain

Distribution and batch traceability

  • Distribution circuit and customer authorizations
  • Batch tracking
  • Serialization and security features

Transport

  • Risk analysis and control of conditions
  • Oversight of transport subcontracting

Returns management

  • Returns procedure
  • Temperature conditions
  • Unique identifier verification

Medicine destruction

  • Certificate of destruction
  • Data Matrix deactivation
  • Subcontracting

R

Resilience & Shortage

Supply continuity and crisis management

Stock shortages management and MITM

  • Medicines of Major Therapeutic Interest (MITM)
  • Shortage reporting (TRUSTMED)
  • Shortage Management Plan (PGP)

Batch recalls

  • Emergency plan and recall procedure
  • Annual simulation - DP-Rappel CNOP

Quality complaints management

  • Complaints handling procedure
  • Reporting to ANSM

Cross-cutting - crisis management

  • 24/7 on-call
  • BCP
  • Archiving
  • Quality risk management (ICH Q9)

U

Urgency & Harmonization

Regulatory alignment and cross-border flows

Import & Export

  • Import (IMPexWeb, NDS-Web)
  • Export - CM-OMS, CLV
  • Distribution and parallel import (AIP)

Packaging materials approval

  • Labeling
  • Serialization
  • Pictograms and Braille
  • Data Matrix and anti-tampering

Control of logistics service providers

  • GxP contracts
  • Regular audits
  • Subcontractor qualification and PR list

Business process optimization

  • AI and automation
  • BPMN 2.0
  • LEAN approach

S

Security & Sovereignty

Quality governance, integrity, and sovereignty

Quality system oversight

  • Overall organization
  • Inspection and audit readiness
  • Risk management
  • Internal and external audits execution

Counterfeits, falsifications, and theft

  • Detection and reporting to ANSM (R.5124-48-2)
  • Prevention - serialization and depositary training

IT security

  • Cybersecurity
  • GxP IT validation (GMP Annex 11) and backups >= 5 years
  • Business continuity

Regulatory archiving

  • Distribution 5 years, MDS 40 years
  • Complaints: expiry + 1 year
  • Recalls: 2 years

Contact

Let's talk

Looking to secure your medicine supply chain? Let's discuss your quality, distribution, and resilience priorities.

Contact DRUS Consulting