Expand globally with Watrem's DTC platform - We help GMP/FDA-certified manufacturers enter consumer markets with minimal risk through our innovative small-batch group buying model (starting at just 4 bottles per SKU).
Our Valued Partners
The Factories We Choose to Cooperate with, Whether They are OEM Factories or Brand Factories Must Possess the Qualifications and Certifications Detailed Below:
NSF Certification
What is NSF certification
NSF certification, issued by NSF International, ensures products (e.g., water treatment systems, dietary supplements) meet strict health, safety, and environmental standards.
What are the certification standards for NSF certification?
Certifying Body: NSF International (an independent third-party organization).
Performance & Safety: Products must remove contaminants without adding harmful substances.
Process: Application submission, factory audits, testing, and annual inspections.
Scope: Covers food equipment, water treatment, and supplements.
GMP Certification
What is GMP certification
Good Manufacturing Practice (GMP) ensures safe, consistent production of pharmaceuticals, food, and medical devices.
What are the certification standards for GMP certification?
US: 21 CFR Part 110 (basic GMP) + HACCP integration
China: GB 14881 (General Hygiene Standard)
Core Requirements：Facility hygiene, equipment validation, raw material control, process monitoring, staff training, traceability, quality testing & stability studies (updated with tech/regulatory changes).
What are the authority of GMP certification?
Mandatory Compliance: Legally required for pharmaceuticals in most countries; uncertified products cannot be marketed.
Global Recognition: Mutual acceptance via PIC/S/ICH frameworks (e.g., EU-U.S. partial alignment) enhances global trade.
Risk Control: Full-process compliance minimizes production risks, ensuring quality and safeguarding corporate reputation.
Consumer Trust: Certified products prioritize safety/consistency, preferred by healthcare buyers and consumers.
FDA Certification
What is FDA certification
U.S. regulatory compliance (not a certification) for food, drugs, and medical devices.
What are the certification standards for FDA certification?
Drugs: GMP compliance (21 CFR Part 210/211).
Medical Devices: Risk-based approvals (510(k), PMA).
Food: FSMA and HACCP compliance.
What are the authority of FDA certification?
Global Gold Standard: FDA sets one of the world's toughest safety benchmarks for food and drugs.
Mandatory Compliance: Bans non-approved products, with penalties including seizures, fines, or prosecution.
Market Gateway: FDA approval is required for U.S. entry of drugs and medical devices.
Science-Based: Decisions rely on rigorous clinical data and expert review.
