Our Certifications & Quality Assurance

Compliance Support

Supporting Your Feminine Care Product Compliance

Complete certification documents, audit reports, COA and MSDS technical files available on request for brand registration.

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ISO 22716 Certified

International cosmetics GMP standard covering full-process quality management

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GMPC Certified

US and EU cosmetics good manufacturing practice quality control

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FDA / MoCRA Support

US FDA registered, compliant with the MoCRA modernization act

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CNAS Accredited

Testing center accredited by the China National Accreditation Service

Why Certified

Why Brands Choose Our Certified Manufacturing

ISO 22716 Quality System

Structured quality management ensures stable production, batch consistency and full traceability.

GMPC Cleanroom Standard

A Class 100,000 cleanroom environment safeguards hygienic production of sensitive products.

Regulatory Documentation Support

We provide the technical dossiers, COA and MSDS required for FDA, MoCRA and EU registrations.

Private Label Formulations

From concept to finished product, we help brands develop customized, high-performance private label lines.

ISO 22716

Cosmetics GMP Standard

GMPC Certified

US & EU Quality Control

Global Compliance

Export Testing & COA

FDA/MoCRA Support

Full Dossier Support

🏭 Cleanroom Manufacturing Environment

✔ Class 100,000 aseptic workshop: operating under strictly controlled Class 100,000 conditions with advanced cleanroom support and standardized SOPs for medical-grade hygienic production.

✔ Higher purity standards: tailored for feminine intimate care, mucosal repair gels and sensitive product categories demanding maximum safety and zero contamination.

* Manufacturing note: All BioCera Labs products are formulated to clinical standards and produced in dedicated high-standard facilities (ISO 22716, GMPC and US FDA registered / MoCRA compliant).

FAQ

Certification & Compliance FAQ

Are your manufacturing facilities ISO 22716 and GMPC certified?

Yes. Our cleanroom facilities operate fully in line with ISO 22716 and GMPC certification standards, ensuring strict hygiene practices, batch consistency and international cosmetics safety standards.

Can you support our brand with FDA registration and US MoCRA compliance?

Yes! While brand owners are responsible for the final product listing, we provide all necessary manufacturing dossiers, facility information, INCI ingredient disclosures and safety test reports for smooth FDA and MoCRA submissions.

What technical documentation do you provide for product registration?

We issue a complete documentation package for every batch, including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), full ingredient breakdown, stability testing and challenge test reports for smooth customs clearance.

Start Your Feminine Care Program Today!

✔ Full product catalog & formulations ✔ Complete regulatory documentation (ISO 22716 & GMPC certified) ✔ Free customized sample box options

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