Industry Solution

Pharma & Healthcare

Maximum Safety
for Patients.

SeriSoft helps pharmaceutical companies meet all regulatory requirements, prevent counterfeiting and ensure end-to-end traceability across the entire supply chain.

✓ EU-FMD Compliant✓ DSCSA Ready✓ GS1 Certified
Pharmaceutical manufacturing
0+
Pharma Clients
0+
Years Expertise
0+
Countries
0.9%
Uptime Guarantee
The Challenge

Patient Safety Is Non-Negotiable.

In the pharmaceutical industry, patient safety comes first. Counterfeit medicines cost lives worldwide. At the same time, regulatory requirements in markets around the globe are constantly growing – from EU-FMD in Europe to DSCSA in the USA.

Increasing regulatory requirements worldwide
1M deaths annually from counterfeit medicines
Complex global supply chains with many stakeholders

SeriSoft has been helping pharmaceutical companies tackle these challenges with reliable, scalable technology for over 20 years.

€4.4T

Global Pharma Market

Value 2024

1M+

Deaths/year

From counterfeits

30%

Counterfeit medicines

In developing countries

100%

Compliance Goal

With SeriSoft

Our Capabilities

What We Deliver for You

Serialization & Track & Trace

Unique serial numbers for every pack with end-to-end traceability from manufacturer to pharmacy.

EU-FMD & DSCSA Compliance

Full conformity with the EU Falsified Medicines Directive and the US Drug Supply Chain Security Act.

Aggregation Management

Linking item, carton and pallet levels for complete visibility throughout warehouse management.

Recall Management

Instant identification of affected batches and efficient coordination of recall actions in real time.

Supply Chain Transparency

Complete visibility across all supply chain stages – from production to point of sale.

Digital Product Passport (DPP)

EU-compliant DPP integration for pharmaceutical products with full lifecycle information.

Use Cases

Who Uses MedTracker & SeriSoft Solutions

From global pharmaceutical corporations to small contract manufacturers – SeriSoft solutions ensure compliance and traceability along the entire pharmaceutical supply chain.

Pharmaceutical Manufacturers & MAHs

Pharmaceutical Manufacturers & MAHs

Manufacturers and Marketing Authorization Holders (MAH) use MedTracker for full EU-FMD and DSCSA compliance. Serialization data is automatically transmitted to national verification systems (EMVS).

EU-FMD compliant · DSCSA ready · EMVS connection

Contract Manufacturing Organizations (CMOs)

Contract Manufacturing Organizations (CMOs)

CMOs serialize on behalf of multiple MAHs. MedTracker supports multi-tenancy, batch management and complete per-client audit trails – without data mixing.

Multi-tenant · Batch management · Complete audit trail

Wholesalers & Distributors

Wholesalers & Distributors

For wholesalers, MedTracker provides verification and traceability along the supply chain – from manufacturer intake to pharmacy dispensing.

Supply chain verification · Traceability · Alerts

Re-Export & Parallel Trade

Re-Export & Parallel Trade

Re-exports and repackaging require re-serialization. MedTracker supports the complete process including de-commissioning, re-commissioning and EMVS connection.

Re-serialization · EMVS connection · Compliance evidence

Regulatory

Every Market. Every Regulation.

Our platform supports all major regulatory requirements. You do not need to worry about individual specifications – we keep systems current so you do not have to.

Automatic updates for regulatory changes
Preconfigured market profiles for 50+ countries
Dedicated compliance support from experts

EU-FMD

Europe (FMD 2019/6)

DSCSA

USA (Supply Chain Act)

ANVISA

Brazil

SFDA

Saudi Arabia

NMPA

GS1-128C

ITS

Turkey

MDR

Medical Devices EU

GS1

Global Standard

MedTracker pharmaceutical solution

MedTracker

The leading pharma serialization platform

Our Solution

MedTracker
Your Serialization Platform

MedTracker is our proven software platform for pharma serialization, track & trace and regulatory reporting – built for maximum compliance with minimum effort.

Real-time serialization on production lines
Automatic reporting to national databases
Multi-market support from a single platform
Integration with existing ERP/MES systems
Easy scaling to new markets & production lines
Encrypted data storage & full audit trail
Our Approach

From the Line to the Market

01

Requirements Analysis

We analyze your markets, lines and regulatory requirements in depth.

02

System Integration

Seamless integration of MedTracker into your existing ERP, MES and line infrastructure.

03

Validation & Go-Live

Complete validation to GxP requirements, guided by our pharma experts throughout.

04

Ongoing Support

24/7 support and proactive monitoring of all systems – we remain your reliable partner.

Get Started

Ready for Complete Compliance?

Speak with one of our pharma experts and find out how SeriSoft makes your serialization strategy future-proof.