Quality & compliance
Quality You Can Verify.
ISO 9001 certified, cGMP compliant, DRAP licensed. Your team is welcome to audit the facility and review every batch record.
Certifications
Certifications.
Full audit records and documentation are available for review once a partnership inquiry is initiated.
Controlled production
Quality is built into every handoff.
From controlled rooms to gloved product handling, our production environment is designed to protect product integrity before release.
What's covered
Validation, stability, and transparency.
We believe in complete transparency with our partners. Comprehensive quality documentation, including process validation reports, stability data, cleaning validation, and vendor qualification records, is available upon request.
The full Site Master File and current audit history are shared under NDA once a partnership inquiry is initiated.
Explore our dedicated facilityDocumentation on request
Available under NDA.
- Site Master File
- Process validation reports
- Stability data
- Vendor qualification records
Start a conversation
Request our quality dossier.
Submit the inquiry form and request an NDA. Our team responds within two business days.
Request a Manufacturing Quote