Building a Fortress of Safety for E-Liquids and Empowering the Industry Through Compliance

In recent years, the e-cigarette industry has experienced rapid growth, accompanied by global regulations that point to a clear direction: enhancing product safety and compliance, and addressing the challenges and opportunities in the global market with innovation.

Since its inception, Zinwi Bio has been committed to building a robust system for product safety and compliance, supporting our OEM factories and brand partners in navigating global challenges and opportunities for mutual growth.

Safety: The Foundation of Industry Development

In a fiercely competitive market, only products with reliable safety and quality can endure. We consistently regard product safety as a fundamental tenet, using a stringent quality control system to ensure each batch of e-liquid meets or even surpasses international standards. From tracing the origin of raw materials to every step of production, we employ advanced analytical instruments for multiple quality inspections, including banned substance screening, compliance testing, and more, ensuring product safety for consumers.

For e-cigarettes, Zinwi has established a comprehensive risk assessment framework based on chemical analysis and toxicological evaluation, covering e-liquids, emissions, and contact materials.

E-liquid: We manage control from the raw materials, controlling the additive levels in e-liquids to ensure component controllability.

Emissions & Contact Materials: We have developed testing methods for harmful and potentially harmful constituents (HPHCs) in emissions and established risk acceptance thresholds, alongside comprehensive emissions analysis. This provides scientific support for the selection of e-liquid packaging materials and device materials.

Additionally, our team actively engages in reverse engineering, continuously optimizing formulations and manufacturing processes to further enhance product safety.

Compliance: The Passport to Global Markets

We have assembled a professional team comprising departments like legal and compliance to conduct relevant research. We’ve built a global industry regulatory database, keeping it updated in real-time to provide clients with comprehensive, customized consulting.

The Pre-Market Tobacco Application (PMTA) is crucial for entering the U.S. market. In light of the FDA's stringent regulations on e-cigarettes and related products, we have established a specialized registration service team to offer complete PMTA compliance services for clients wishing to enter the U.S. market. Our expert team, composed of seasoned R&D personnel, chemists, toxicologists, testing experts, regulatory experts, and system specialists, possesses deep industry knowledge and practical experience, offering customized services from initial product development to final application submission.

PMTA Service Range

U.S. PMTA STN Application Services, TPMF Application Services, PMTA System Guidance

Customer FDA CTP Portal Account Application; collecting, writing, compiling, and submitting product application documents; acquiring STN numbers; assisting clients with TPMF document submissions; factory system gap analysis; system guidance and document improvement; on-site system audit responses.

Other Registration Services

Collaboration: Engine Driven by Innovation

We believe that open collaboration is a key driver of industry progress. Our partnerships with OEMs and brand owners extend beyond production, focusing on technology sharing and innovation breakthroughs. We have established a series of communication platforms, including innovation technology seminars, e-liquid and device compatibility labs, and global innovation flavor tasting events, keeping our partners aligned with industry frontiers. We not only share the latest R&D outcomes and market trends but also help partners identify potential risks and optimize product portfolios through case analysis, supporting evolving consumer needs.

Join Hands, Create New Chapters

In a rapidly changing and competitive market, ensuring product safety and compliance is our collective responsibility and goal. We invite all OEM and brand partners to join us in delving into technological innovation, adhering to quality standards, and advancing confidently towards larger and more distant markets. Through relentless efforts and deep collaboration, we firmly believe a brighter future for the industry awaits.

Let us work together for the healthy and sustainable development of the industry, climbing to new heights. Build trust through quality, secure the future through compliance!