RegenCell Global as a distributor of stem cell products, our regulatory responsibilities are distinct from those of the manufacturers, yet equally critical in ensuring compliance across the supply chain. While all aspects of product development — including sourcing, processing, packaging, shipping and certification — are handled by our GMP-certified manufacturing partners, we maintain strict oversight of the regulatory status of each product we distribute. We ensure that all manufacturers adhere to relevant local and international regulations, including those set by agencies such as the FDA, EMA, or regional health authorities, depending on the market of distribution. This includes verifying that products are approved or registered where required, properly labeled, and accompanied by all necessary documentation such as Certificates of Analysis, Material Safety Data Sheets (MSDS), and batch tracking records. Our role as a distributor includes maintaining compliance with import/export regulations, cold chain logistics, and traceability standards, as well as ensuring that our operations align with best practices in product handling, storage, and distribution.

By working closely with our manufacturers and regulatory consultants, we help bridge innovative stem cell technologies with the clinical and research markets, all while upholding the highest standards of legal and ethical

Compliance

RegenCell Global Corp. strictly adheres to all regulatory requirements set forth by the FDA, GMP, and ISO standards. Our products are sourced from manufacturers who follow the highest ethical standards in stem cell collection, processing, and storage. We provide complete traceability for every product we distribute, ensuring that each one meets the rigorous safety and quality guidelines set by governing bodies.”

Certifications

All our products are manufactured in FDA-registered facilities and comply with GMP and ISO 13485 certifications. We work closely with trusted manufacturers who meet these exacting standards to ensure the highest quality stem cell therapies.

Chain of Custody

Our stem cell products are transported using temperature-controlled logistics systems, ensuring that every product maintains its integrity from point of origin to final destination. We adhere to strict cold-chain management procedures, maintaining optimal temperatures throughout the transport process to preserve the quality of the stem cells.

Note: RegenCell Global as a specialized distributor of stem cell products, we operate with a strong commitment to regulatory and ethical compliance across every step of our distribution process. While manufacturing, certification, packaging, and shipping are the responsibility of our qualified partners, we play a vital role in ensuring that all products we distribute meet applicable regulatory, legal, and ethical standards in their respective markets. We conduct thorough due diligence on all manufacturers to confirm compliance with Good Manufacturing Practices (GMP), applicable regenerative medicine regulations, and relevant certifications such as FDA registration, CE marking, or other country-specific approvals. Our compliance responsibilities also include ensuring accurate product labeling, maintaining full traceability and batch tracking, and adhering to cold chain and storage requirements as specified by the product’s regulatory guidelines. In addition, we comply with import/export regulations, maintain clear documentation, and ensure that our internal procedures align with best practices for quality assurance, risk mitigation, and data integrity. By working closely with manufacturers, regulatory consultants, and our clients, we ensure that all distributed stem cell products are handled responsibly, ethically, and in full alignment with national and international compliance frameworks.