Press Release

PEMAY Biomedical Strengthens Brand Compliance and Competitiveness Through Scientific Validation in the New PIF Era

The Skin Research Institute integrates exosome technology, human efficacy testing, and comprehensive OEM/ODM services

As the Product Information File (PIF) system continues to be fully implemented, Taiwan’s cosmetics industry is entering a new era that places greater emphasis on safety assessment, scientific evidence, and data traceability. From raw material sourcing, formulation design, and manufacturing processes to stability testing, product safety, and efficacy claims, brands are now required to establish complete, consistent, and well-documented product information. For companies, developing a competitive product is no longer only about creating distinctive concepts. It is also essential to support product quality, safety, and stability with reliable scientific data.

In response to regulatory changes and the rapid growth of the exosome skincare market, PEMAY Biomedical has established the Skin Research Institute as its core scientific and technical platform. The institute integrates a Quality Control Laboratory, Biotechnology Laboratory, Formulation Development Laboratory, and Cosmetic Human Efficacy Testing Laboratory, creating a comprehensive research system that covers cellular research, raw material analysis, formulation development, quality management, and human efficacy evaluation.

Under the research concept of “Efficacy at Scale, Safety Decoded,” PEMAY Biomedical connects the expertise and data generated by each laboratory, allowing quality control and regulatory considerations to be incorporated from the earliest stages of product development.

The Quality Control Laboratory is responsible for monitoring raw materials, semi-finished products, and finished goods, while maintaining systematic traceability throughout the manufacturing process. The Biotechnology Laboratory focuses on cellular technology and dual-source exosome research. The Formulation Development Laboratory combines botanical extracts, biotechnology-derived ingredients, and precision formulation techniques to develop product textures, dosage forms, and stability solutions. Meanwhile, the Cosmetic Human Efficacy Testing Laboratory conducts participant screening, instrumental measurements, and clinical data analysis to provide brands with more credible and measurable support for product efficacy.

For the rapidly emerging field of exosome-based skincare, the Skin Research Institute has established a GTP-grade clean and sterile laboratory environment and continues to conduct research on exosome stability, formulation compatibility, and delivery applications. PEMAY Biomedical also applies its proprietary Exo-Link exosome delivery technology to address potential stability challenges during room-temperature storage and cosmetic formulation development.

Through systematic research and verification procedures, PEMAY Biomedical aims to transform advanced biotechnology from a conceptual selling point into a practical solution that can be incorporated into skincare product development, manufacturing, and quality management.

Under the PIF framework, one of the greatest challenges for brands is not simply the preparation of documents. The real issue lies in ensuring that raw material specifications, INCI ingredient names, formulation data, manufacturing records, stability testing, safety assessments, and efficacy evidence are complete, consistent, and mutually traceable. When these elements are not properly integrated during the early stages of development, brands may later face additional costs associated with supplementary testing, document revisions, formula adjustments, or regulatory corrections.

To help companies reduce development risks and regulatory management costs, PEMAY Biomedical provides a comprehensive one-stop OEM/ODM solution. Its services cover market positioning, product planning, ingredient selection, formulation research and development, prototype sampling, manufacturing, quality inspection, third-party testing, and assistance with PIF preparation and documentation.

By establishing product data directly from the source, PEMAY Biomedical helps ensure consistency among formulation development, manufacturing processes, testing results, and regulatory records. This integrated approach improves the efficiency of future inspections, product tracking, document updates, and market management, while allowing brands to respond more confidently to evolving regulatory requirements.

In addition to its scientific research and manufacturing capabilities, PEMAY Biomedical has continued to accumulate achievements in international competitions, product innovation, and biotechnology development. These accomplishments demonstrate the growing competitiveness of Taiwan’s biomedical skincare industry in terms of product quality, technical expertise, and international market potential.

The Skin Research Institute uses scientific data as the foundation of product communication, helping brands develop skincare solutions that are not only differentiated and marketable, but also supported by safety, stability, and measurable evidence.

Looking ahead, PEMAY Biomedical will continue to deepen its research in exosomes, biotechnology-derived ingredients, formulation development, and human efficacy testing. By combining scientific validation, comprehensive PIF documentation support, and integrated OEM/ODM services, the company aims to become a reliable research and manufacturing partner for brands navigating regulatory transformation and increasingly competitive markets.

Through this approach, PEMAY Biomedical is committed to working with brand owners to develop the next generation of skincare solutions—products that unite scientific evidence, market differentiation, manufacturing feasibility, and regulatory compliance.