Quality & compliance

The evidence wall.

The certifications, documentation posture, and audit history that show up in diligence — assembled in one place.

01 — Certifications

Audited, current, and Maxwell-owned.

Quality management

2015

Quality management systems for design, development, and manufacturing of peptoid intermediates and APIs.

Environmental

2015

Environmental management systems covering waste streams, solvent recovery, and energy use.

Occupational health

2018

Health and safety management for hazardous chemistry handling and large-scale operations.

Manufacturing

Inspected

Good Manufacturing Practice for peptoid APIs intended for clinical and commercial supply.

Sustainability

Recognized

Sustainable supply chain partner with documented Scope 1/2 emissions and reduction commitments.

Pharmacopoeia

Aligned

Analytical methods validated to USP, EP, and JP general chapters for impurity profile and assay.

Master batch records, deviation logs, change control. Full traceability from starting materials through release.

Annual surveillance audits passed. Customer audits welcomed. NDA-gated dossier available on request.

NDA-gated. Certificate copies, audit history, and SOP index.

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