Country Compliance implementation for pharma

Make TraceLink country reporting work across all your markets, partners and systems.

Global serialisation and track-and-trace rules have turned compliance reporting into a continuous, multi-country programme. The regulations differ by market, the data expectations keep shifting, and every new country adds more partners and interfaces to your landscape.

Two colleagues having a meeting in an office with large windows, one smiling woman and one man writing notes at a desk with a laptop.

Amalia helps pharmaceutical and biotech companies implement TraceLink Country Compliance in a structured, reusable way. Our TraceLink-experienced consultants work as a single team with your internal stakeholders, contract partners and TraceLink to design, configure, test and deploy country modules without disrupting supply.

Why Country Compliance Implementation Matters

The number of track-and-trace and serialisation regimes continues to grow: Amalia implements TraceLink Country Compliance modules for EU FMD, DSCSA, Russia Compliance, Saudi Arabia, UAE, Bahrain, Indonesia, Kazakhstan, Uzbekistan, India, China, South Korea and an expanding list of emerging markets.

Without Tracelink Country Compliance

TraceLink is the market leader with its scalable Country Compliance platform that delivers market-specific applications on top of a common, cloud-based architecture. But the platform alone does not guarantee success. Companies still have to:

Interpret each country’s data and reporting rules

Connect TraceLink to ERP, WMS, L3, CMOs and MAHs

Align master data and serialisation processes

Co-ordinate onboarding with internal teams and external partners

With Tracelink Country Compliance

Poorly planned implementations can lead to failed go-lives, incompliance with regulations, shipment holds, high manual effort and, in the worst case, loss of market access. Competitors that advertise “rapid deployment” often under-estimate partner onboarding, data quality and testing effort, leading to rework and second-round implementations.

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A well-run TraceLink Country Compliance implementation should instead:

Create a repeatable pattern you can reuse for each new market with minimal process deviations

Minimise disruption to packaging, logistics and commercial operations

Reduce validation and testing effort through standardisation

Give you clear, consolidated visibility of global compliance status

Allow for a systematic approach to identify, manage and implement regulatory and solution updates

What We Do Under Country Compliance Implementation

We follow a systematic, repeatable approach that lets you scale from one country to many while keeping risk under control. In addition, our TraceLink certified colleagues are embedded throughout the work, and can act as TraceLink "internal "resources.

Clarify scope, markets and partners

Design the end-to-end architecture and processes

Country solution design – market-specific requirements

Configure and deploy TraceLink

Test end-to-end flows and qualify the solution

Prepare partners, operations and quality for go-live

Go-live support, hypercare and transition to “operations”

Step 1

Clarify scope, markets and partners

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We start by creating a shared picture of what is in scope:

Current and target markets, timelines and regulatory deadlines

In-scope TraceLink applications (Master Data Exchange, Serial Number Exchange, Serial Number Manager, Serialized Operations Manager, EU Compliance, NMVS, DSCSA, etc.)

Internal systems (ERP, WMS, L3 line systems, master data) and integration points

External partners (CMOs, 3PLs, distributors, MAHs, affiliates) and their readiness

Our dedicated Business Analysts and Project Managers lead this scoping phase, working with supply chain, QA, IT and serialisation leads to define realistic waves, dependencies and governance.

Step 2

Design the end-to-end architecture and processes

we design how TraceLink Country Compliance fits into your architecture and ways of working:

High-level processes for serialisation and reporting flows (commissioning, aggregation, shipping, returns, decommissioning)

Positioning of TraceLink vis-à-vis existing L3 and ERP solutions

Data ownership and master-data alignment across markets and partners

Our TraceLink Consultant and Business Analysts lead the technical design with your IT teams and TraceLink where needed, while the PM keeps business, quality and regulatory stakeholders aligned.

Step 3

Country solution design – market-specific requirements

For each market or wave, we then define country-specific design and configuration:

Mapping of legal and regulatory requirements into TraceLink capabilities (events, messages, timelines, data fields)

Detailed flows for typical and edge-case scenarios (e.g. intra-EU trade, re-pack, free goods, samples, returns)

Partner roles and responsibilities (who sends what, when, and with which identifiers)

Country-specific testing and validation expectations, referencing your CSV / CSA and GxP quality system

We design each market with future reuse in mind, so that patterns can be applied to later countries instead of starting from zero every time.

Step 4

Configure and deploy TraceLink

Once designs are agreed, we move into configuration and integration:

TraceLink tenant alignment and environment strategy (TEST/PROD)

Configuration of relevant Country Compliance apps and supporting modules

Interface design and implementation with ERP, WMS, L3 and partners (file, API, EPCIS, etc.)

Configuration of routing, partner links and packaging hierarchies in TraceLink

Creation of the Design Document (DD), Configuration (CS) and Design Specification (DS) documents

Here the TC leads the technical work, supported by your IT teams and relevant vendors, while the PM manages plan, risks, issues and cross-functional decisions.

Step 5

Test end-to-end flows and qualify the solution

We then structure and run testing and qualification tailored to your risk profile:

Unit and integration testing for interfaces and message flows

End-to-end scenario testing from packaging line or ERP through to regulatory hubs and back

Negative and exception scenarios (rejections, partial shipments, returns, recalls)

Performance and volume checks where needed

Evidence and reports to support CSV / CSA validation and infrastructure qualification, aligned with your GxP framework

We emphasise traceability from requirements to tests and results so that compliance reporting stands up in audits and inspections.

Step 6

Prepare partners, operations and quality for go-live

Country compliance only works if partners and internal teams are prepared. We support:

Partner onboarding, testing and cutover planning with CMOs, 3PLs and distributors

Operational procedures and work instructions (for packaging, logistics, planning, serialisation teams)

Quality-system updates (SOPs, deviation and CAPA handling, change control)

Training for local markets, serialisation teams and IT support

Your IPM co-ordinates cutover readiness and risk reviews, while the TC ensures technical cutover and rollback options are understood.

Step 7

Go-live support, hypercare and transition to “operations”

After go-live, we stay close until the new reporting is stable:

Hypercare support for live issues in TraceLink, ERP and partner flows

Fine-tuning of configuration based on real-world exceptions

Handover to BAU teams, including country-specific runbooks and escalation paths

Where you plan additional markets, we take the lessons learned from the first implementation and build an agreed template so future countries move faster with less risk.

TraceLink Country Compliance markets we support

TraceLink’s Country Compliance suite currently covers more than 35 markets. Today this includes, amongst others:

European Union Falsified Medicines Directive (EU FMD)

National Medicines Verification System (NMVS)

U.S. Drug Supply Chain Security Act (DSCSA)

Russia
Pharmaceuticals

Russia
Crypto Code

Russia Biologically Active Food Supplements (BAFS)

Saudi Arabia
Pharmaceuticals 

United Arab Emirates
Pharmaceuticals

Bahrain
Pharmaceuticals 

Kazakhstan
Pharmaceuticals

Uzbekistan
Pharmaceuticals 

Indonesia
Pharmaceuticals

India
Pharmaceuticals 

China
Pharmaceuticals 

South Korea
Pharmaceuticals 

Deliverables

A TraceLink Country Compliance implementation with Amalia typically produces:

Work Breakdown Structure

Markets, timelines, dependencies and partner onboarding strategy. 

End-to-end architecture and process design

Target flows across packaging lines, ERP, WMS, partners and TraceLink, with clear roles and responsibilities. 

Design documents

For each market, covering legal requirements, TraceLink configuration, message flows, data mapping and exception handling.

Configuration specifications

Technical specs and mapping for interfaces with ERP, WMS, L3 and partner systems (including EPCIS events where relevant).

Test strategy, scenarios and evidence

Risk-based test plans, test cases and results for end-to-end and country-specific scenarios, usable as part of CSV / CSA documentation. 

Cutover and hypercare plan

Including partner readiness, rollback strategy and hypercare procedures. 

Operational and quality documentation

Inputs to SOPs, work instructions and training materials for serialisation, supply chain and IT support teams.

Throughout, our resources take full ownership and responsibility for the technical design, build and integration, working as one integrated team with you.

Customer Stories & Insights

From Vision to Execution: Our Strategic Framework

The gap between a strategy document and functioning corporate governance is almost entirely about two design choices: how specific the values are, and how deeply the framework integrates with operational processes.

Inside the Quality Management System — We Built to Scale

A formally compliant QMS and a functional one are not the same thing. For a life sciences consultancy, the difference comes down to calibration — and the discipline to build something proportionate rather than just correct.

We will be adding more customer stories soon. Please check other categories till then

We will be adding upcoming webinars soon. Please check other categories till then

Outcomes you can expect by working with Amalia

A man in a white shirt writing in a notebook while a woman in a black blazer smiles and listens during a meeting in a modern office.

Faster, more reliable market go-lives

Structured waves and realistic plans that reduce last-minute surprises and shipment risk. 

Reusable patterns for new countries

A standardised way of designing, integrating and validating country modules, so each additional market is easier. 

Stronger compliance and audit readiness

Clear traceability from regulations through to TraceLink configuration, test coverage and operational controls. 

Better collaboration across partners

Clearer expectations and onboarding for CMOs, 3PLs and distributors, reducing manual corrections and disputes. 

Lower total cost over time

Fewer failed implementations, less custom one-off work and a more flexible TraceLink landscape that can handle new mandates. 

When to Consider TraceLink Country Compliance Implementation

Five people having a meeting at a table with notebooks and glasses of water near large windows.

Implementing TraceLink TTS or Country Compliance for the first time

Adding new markets (for example, Saudi Arabia, UAE, India, China, Brazil, Kazakhstan or other emerging markets) to an existing TraceLink instance

Replacing a previous serialisation system / compliance solution with TraceLink

Remediating a struggling or partially implemented TraceLink programme

Preparing for near-term regulatory deadlines or audits that will focus on serialisation and country reporting

Why Amalia

We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.

Simplicity by design — no unnecessary complexity

We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.