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REACH Registration & Compliance Support  QbD Group

REACH Registration & Compliance

Preparing to register substances under REACH?

Whether you're registering a new substance, updating an existing dossier, or expanding your market access in the EU/EEA, REACH compliance demands precision, strategy, and up-to-date data.

At QbD Group, we help you navigate every step, from substance characterization and IUCLID dossier build to SDS authoring and Chemical Safety Reporting. With our expert support, you can register with confidence and stay compliant.

 

What is REACH registration?

Under REACH, all chemical substances manufactured or imported into the EU/EEA in quantities of 1 tonne or more per year must be registered with ECHA.

The obligation usually applies to:

  • EU/EEA manufacturers

  • Importers of substances or mixtures from outside the EU/EEA

  • Representatives acting on behalf of non-EU companies

Registration is based on the “one substance, one registration” principle and is submitted digitally via the REACH portal using IUCLID.

Why is it important?

Accurate substance identity and composition data are the foundation of a successful dossier. They help to:

  • Avoid duplicate testing and unnecessary costs

  • Ensure reliable hazard and risk assessments

  • Streamline the evaluation process and reduce post-submission questions

Getting the fundamentals right – such as SIP, analytics, impurities, and use mapping – saves time, money, and effort throughout the registration.

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How can we help?

No matter where you are in your REACH journey, we can plug in with targeted services or deliver a fully managed program.

REACH Dossier Registration

REACH Dossier Registration

QbD Group helps you complete and prepare REACH dossiers by compiling the analytical and regulatory documentation required for successful registration, fully aligned with the “one substance, one registration” principle. These steps are essential to avoid rework and ensure consistent dossier decisions. Our support includes:

  • Substance Identification Profile (SIP), substance identification and analytical data package

  • Qualitative and quantitative composition profile (constituents and additives)

  • Impurity assessment aligned with the SIP

  • Data Gap Analysis to identify missing or inadequate information, ensuring the dossier meets all Annex VII–XI requirements.

  • IUCLID data entry and documentation upload

Safety Data Sheets (SDS) & Extended SDS

Safety Data Sheets (SDS) & Extended SDS

We draft and maintain REACH-compliant Safety Data Sheets (SDS) in accordance with Annex II (16 sections), including extended SDS for substances or mixtures that require exposure scenarios (typically ≥ 10 t/y).
Our services cover:

  • Authoring of SDS and extended SDS

  • Updates following changes in classification, uses, or hazard data

  • Biosafety/biosecurity assessments where relevant

Chemical Safety Report (CSR)

Chemical Safety Report (CSR)

For substances requiring a CSR, we provide end-to-end support—from data collection to dossier submission.
Our services include:

  • Hazard assessment (human health, physicochemical, environmental, PBT/vPvB)

  • Exposure assessment and risk characterization

  • CSR preparation and submission in IUCLID

  • CSR updates based on new data, uses, or regulatory changes

Why QbD Group?

  • End-to-end toxicology support
    From early development to post-approval changes, we provide integrated risk assessments seamlessly aligned with QA, CMC, and regulatory strategies.
  • Trusted expertise at scale
    With decades of combined experience across diverse projects and markets, our toxicology team provides reliable insights that add efficiency, consistency, and confidence to every assessment.
  • Proactive compliance monitoring
    Through strict oversight of reports, we help clients stay in full control of toxicology obligations, proactively alerting them to potential non-conformities before they become risks.
  • Certified Toxicology Experts 
    Our reports are prepared and reviewed by EUROTOX-certified (ERT) toxicologists, ensuring the highest standards of scientific quality, regulatory reliability, and patient safety across every assessment.


    EUTOTOX

End-to-end toxicology support

10+ years of experience

Compliance monitoring

Certified toxicology experts

 

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Ready to take te next step?

Let QbD Group guide you through the complexities of REACH registration and compliance. Contact us today to discuss how we can support your submission.

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