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Regulatory Documentation & Quality Assurance

At Alkan Chemical Europe, regulatory integrity and quality assurance are at the core of everything we do. We understand that access to accurate, complete, and audit-ready documentation is essential for manufacturers operating in highly regulated industries.

Our partners rely on us not only for premium-quality raw materials but also for our proactive support with global regulatory compliance, documentation management, and technical transparency.

Regulatory Documentation & Quality Assurance

At Alkan Chemical Europe, regulatory integrity and quality assurance are at the core of everything we do. We understand that access to accurate, complete, and audit-ready documentation is essential for manufacturers operating in highly regulated industries.

Our partners rely on us not only for premium-quality raw materials but also for our proactive support with global regulatory compliance, documentation management, and technical transparency.

Comprehensive Regulatory Documentation

We provide full documentation packages tailored to your approval process, quality audits, or CTD submissions. Depending on the product and application, our documentation offering includes:

TDS (Technical Data Sheets)

Product specifications, intended uses, physical and chemical properties

SDS (Safety Data Sheets)

Safety handling, transport, and storage compliance as per CLP and GHS standards

CoA (Certificates of Analysis)

Batch-specific results with signed QC release for every delivery

DMF (Drug Master File) and ASMF Support

When applicable, we supply open-part DMFs or assist in contacting the manufacturer for closed-part documentation

GMP, ISO, and Halal Certifications

Available upon request and according to product type and country of origin

Statement Letters

BSE and TSE-free declarations, GMO statements, allergen declarations, residual solvent status, and more

Quality Assurance Throughout the Supply Chain

Sourcing from audited manufacturers across Europe and Asia with traceable production systems
Batch-by-batch compliance verification before release
EU warehouse handling aligned with GDP storage practices
Regular documentation reviews to maintain up-to-date compliance with international standards
Support for customer audits and document validation procedures

Supporting Your Regulatory Submissions

Our experienced team supports your regulatory and R&D departments with:

Prompt document delivery for internal evaluations and dossier preparation

Assistance in responding to local authority queries including EMA, SFDA, JFDA, and EDA

Follow-up on updated monographs, certificate renewals, and compliance updates

Trust Built on Transparency

With Alkan Chemical Europe, you gain more than just compliant ingredients. You gain a reliable partner dedicated to ensuring that every product you receive is supported with complete, verifiable, and traceable documentation.

Contact us to request a documentation package or to verify product registration and dossier availability.

Trust Built on Transparency

With Alkan Chemical Europe, you gain more than just compliant ingredients. You gain a reliable partner dedicated to ensuring that every product you receive is supported with complete, verifiable, and traceable documentation.

Contact us to request a documentation package or to verify product registration and dossier availability.

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