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GLOBAL IVD SOLUTION

Global Regulatory & Registration Services

Accelerating your access to international IVD markets with expert-driven regulatory support. From documentation to full market authorization, we help you navigate complexity with confidence.

Global Market Access

Proven Regulatory Experience Across Global Markets

Our regulatory team supports market access in 99 countries and regions, covering all major continents.

United StatesMexicoPanamaBelizeDominicaCosta Rica

CHOOSE THE RIGHT LEVEL OF SUPPORT

Flexible Levels of Regulatory Support

Start with the level that matches your internal capability. Every engagement can expand as your registration needs evolve.

Level 02Guided

Extended Regulatory Support

A structured regulatory workstream that connects strategy, dossier preparation and authority responses.

Included Support

  • Market-specific pathway and evidence mapping
  • Full dossier preparation and gap resolution
  • Ongoing coordination through authority questions

Pricing is tailored to project scope, target market and the level of support required.

DOCUMENTATION-LED REGULATORY SUPPORT

How We Support Your Registration

CLIENT / LOCAL PARTNER LEADS

Market decisions · Local submission · Authority liaison

ATLAS LINK SUPPORTS

Manufacturer documents · Technical clarification · Response support

Step 01 of 06

Align Product & Market Scope

You define the target market and registration route. We confirm the exact product scope, intended use, variants and available evidence so our documentation support starts from the right baseline.

Documents & Outputs

  • Confirmed product scope
  • Document request list
  • Delivery plan

How We Work With You

  1. You share the target market, product scope and local request
  2. We confirm product identity, claims and available approvals
  3. Together we agree document priorities and delivery timing
01 / 06

Real-World Registration Cases

Sep 2023 · Saudi Arabia (SFDA)

Legal Manufacturer Representation

Acted as Legal Manufacturer establishing a robust registration template. Successfully facilitated market entry resulting in a 1 million test volume rollout.

Middle East Focus

Apr 2024 · Thailand (TFDA)

Exclusive Distribution Rights

Managed full registration lifecycle securing exclusive distribution rights. Achieved rapid compliance approval supporting a 400,000 test volume distribution.

APAC Expansion

Aug 2025 · Germany (BfArM)

IVDR Transition Execution

Guided complex transition from IVDD to IVDR. Executed necessary product redesign documentation for compliance, successfully updating the CE certificate.

Ongoing Transition

Start Your Registration Journey

Tell us your target market and product details—our regulatory experts will guide you through the next steps toward seamless market entry.

Contact Us