Greetings from Freyr China
Freyr is a leading Regulatory solutions provider offering comprehensive services to life sciences firms across the regulatory spectrum. With a robust presence spanning over 120 countries, we facilitate the "local to Global" journey for life sciences companies. In China, Freyr China plays a pivotal role in assisting companies with Drug registration in China under the National Medical Products Administration (NMPA). Our services encompass Regulatory Strategy formulation, Market Intelligence, In-country representation, Post-Market Surveillance (PMS) functions, and more. Additionally, we provide cutting-edge Regulatory software solutions tailored to streamline the entire NMPA registration life cycle covering everything from the China new drug approval process to China generic drug approval process.
Industries We Serve
Discover tailored solutions across pharmaceuticals, life sciences, consumer goods, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market.
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 MoreChina is one of the fastest-growing markets for Medical Devices, where the demand for devices is majorly met through imports. NMPA (National Medical Products Administration) ,formerly known as CFDA and the Centre for Medical Device Evaluation (CMDE) are responsible for the review of the Medical Device import registration applications of all the three (03) classes of devices (Class I, II & III). As per NMPA regulations, an NMPA legal agent must be appointed to serve as a representative of overseas pharmaceutical and medical device companies applying for China Medical Device Registration.
Know MoreIn 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 MoreBeing 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
About Freyr
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 MoreOur Regional Expertise
We are a global firm and we have local expertise across the following countries.