Greetings from Freyr China
Freyr is a global Regulatory leader providing services and solutions to Life Sciences companies in their entire Regulatory value chain. With our presence in 120+ countries, we support Life Sciences companies in their “Local to Global” journey. At Freyr China, we support companies to register their products with the NMPA, Regulatory strategy, Market Intelligence, In-country representation, PMS functions, and more. We also offer next-gen Regulatory software solutions that cover the complete registration lifecycle.
Industries We Serve
As the world’s best pharmaceutical manufacturing powerhouse, China offers a good deal of business opportunities for pharma manufacturers. Not only have the Chinese pharmaceuticals seen a rise in FDA approvals for generic medication, but also the market seems ambitious with a focus on innovation and homegrown research and development. To enter the Chinese pharmaceutical market, one needs to obtain approvals from the National Medical Products Administration (NMPA). With proven Regulatory affairs consulting, Freyr assists manufacturers right from market strategy to dossier submissions and dossier compilation to the NMPA for the registration, to reduce the drug’s time to market.Know More
China is one of the fastest-growing markets for medical devices, where the demand for devices is majorly met through imports. The NMPA, formerly the CFDA, and the Centre for Medical Device Evaluation (CMDE) are responsible for the review of the medical device import registration applications of all three (03) classes of devices (Class I, II, & III). With clear-cut knowledge of the local Regulatory landscape, Freyr guides manufacturers in successfully conducting local testing & clinical testing (if needed), and documents compilation as regulated by the NMPA. Freyr supports clients in obtaining various certifications and compiling documentation that leads to market approval within strict timelines. Freyr provides end-to-end Regulatory services for pre- and post-marketing activities of medical devices.Know More
In China, a food product is regulated under the State Administration for Market Regulation (SAMR), a combination of formerly China Food and Drug Administration (CFDA), Administration of Industry and Commerce (AIC), & Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ). Freyr’s experts can assist you in any kind of food supplement Regulatory requirement in China such as food product classification, formulation/ingredient assessment, label & claims review, technical dossier compilation, submissions to the Health Authority, and many more.Know More
Being the largest economy in Asia, it is no wonder that China is an attractive destination for cosmetic manufacturers. With a high rate of consumption and an ever-increasing consumer base, the Chinese cosmetic market experiences steady growth. As a leading global Regulatory partner, Freyr has extensive experience in providing cosmetic Regulatory services in China. Our team of Regulatory experts assists manufacturers to decode the China cosmetics registration process and ensure end-to-end compliance according to the China Cosmetic Supervision and Administration Regulation (CSAR).Know More
Freyr is one of the largest, global, Regulatory-focused solutions and services companies for the Life Sciences industry supporting, large, medium, and small size global life sciences companies (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics) in their entire Regulatory value-chain, ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions, etc. to Post- Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions. Freyr is also expanding its footprint into other key areas like Pharmacovigilance.Know More
Our Regional Expertise
We are a global firm and we have local expertise across the following countries.