axcura
Quality & compliance

Assurance you can document.

From qualified sourcing to analytical release, every material follows a defined path — so you can match the level of assurance to your application and back it with documentation.

Our approach

Built in, not bolted on.

Axcura operates a robust Quality Management System aligned with ISO 9001:2015 and PIC/S GDP. Every activity — sourcing, distribution and documentation — is compliant with Swissmedic and EU regulatory frameworks, and batch release is overseen by a contracted Qualified Person.

Independent analytical work is carried out through an ISO/IEC 17025-accredited partner laboratory, so the data behind every release is defensible and traceable.

How we qualify

Two programs, matched to your application.

Every material passes a defined qualification path, so you can match the level of assurance to your application.

Standard assurance

Trusted Goods (TG)

Materials are presented and distributed under the original manufacturer’s name, supported by Axcura’s document-based technical vendor and material assessment.

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Heightened assurance

PureOne™

Distributed under the Axcura name with heightened scrutiny: technical vendor qualification plus analytical material qualification.

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Standards & authorizations

Backed by concrete authorizations.

Our quality system is backed by concrete authorizations and independent accreditations.

  • Swissmedic GDP authorization

    GDP-CH-1006386

    Import, wholesale distribution and export of active substances (human and veterinary), stored and physically distributed by our qualified GDP/GMP 3PL partner.

  • ISO 9001:2015

    Accredited quality management system covering continuous improvement and the handling of excipients and biopharma ingredients.

  • ISO/IEC 17025

    Analytical testing and calibration competence, accredited through our partner laboratory.

  • Swiss NarcA / BetmKV

    Authorization for the secure handling and distribution of controlled substances.

  • Contracted Qualified Person (QP)

    Batch-release services under Swiss / EU pharmaceutical law.

Need documentation for a specific material?

Tell us the substance and the assurance level you need — we'll share the qualification path and the certificates available.

Talk to Axcura