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Freyr Expertise

  • Product evaluation and classification according to the NMPA regulations
  • Product registration with the NMPA, SMAR, and NHC
  • In-country representation (MAH/DMAH/Responsible Agent in China)
  • Interactions with the NMPA, SMAR, and NHC
  • Market and Regulatory intelligence
  • Query support management
  • Product compliance maintenance
  • Ad-hoc Regulatory consultation
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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.

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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.

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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.

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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).

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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.

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Our Regional Expertise

We are a global firm and we have local expertise across the following countries.

Freyr Digital

  • Freyr SUBMIT PRO
    Freyr SUBMIT PRO, an eCTD Software that Suits All Your Submission Requirements
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  • Freyr IMPACT
    An Innovative, Cloud-hosted, AI/ML enabled Regulatory Intelligence platform offering a complete spectrum of authoritative Regulatory Information
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  • Freyr Label 360
    Content to Carton - A One-stop Solution to All Labeling Needs
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  • Freyr PRISM
    Freyr SPAR is one such RIM solution that enables life sciences organizations to effectively manage their information, right from tracking product registrations to generating statistical reports
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  • Freyr PRISM
    Create, capture, manage, deliver, monitor, and archive Regulatory data with an end-to-end electronic document management system
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  • Freyr PRISM
    Inquisitive process to track dossiers, submissions, submissions to HA queries, and tasks to meet the challenges of eCTD mandates across the globe
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  • Freyr PRISM
    Largest global ingredients repository and Regulatory database to support digitization of formulation assessment and real-time intelligence
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  • Freyr PRISM
    A robust platform to create, validate, store, and submit complex content structures aligning with the SPL’s (FDA) and the SPM’s (HC) standard control vocabularies and validation rules
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Meet Our Experts

  • Summer XIA

    Medical Devices Regulatory Operations Lead

    Summer brings in a rich practical experience of 10+ years in Compliance/QA/RA. She is an expert in multinational and multicultural team coordination. She specializes in medical devices and is seasoned in driving high-quality NMPA registration approvals and enhancement of the QMS framework. Her core strength lies in the deep understanding of the medical device Regulatory landscape in China, North ASEAN, and the South Asia region.

  • QiRui CHEN

    Cloud Platform Director in Freyr China

    QiRui comes with more than 20 years of experience in the Software Industry. With over a decade of management experience, QiRui has also proven to be a leader. With his proficiency in Java, Python, Distribution Architecture, and Cloud, he brings dynamic and polished expertise to the team.

  • Eigen ZHOU

    Director of Application Development of Freyr China

    Eigen is a proven technical maestro with over 15 years of experience in the ICT industry. He is driven by creativity and innovation and has expertise in full-stack application development, big data, and machine learning technology. With a comprehensive career in world-renowned companies, such as Gameloft, Nokia, and JD.com, he brings solid knowledge of software technology development and architecture to the table.

  • Jenny ZENG

    Responsible for Consumer Group in Freyr China

    Jenny has over 30 years of experience in Cosmetics, Food and Beverage Safety, and Nutrition. She has mastered the NMPA regulations and is a Regulatory Affairs leader. She has led multiple Cosmetics and Food registration projects on local and global levels. Jenny has been a prestigious member of multiple government committees.

  • Chongyu LIU

    Manager-Submission and Planning

    Chongyu is a Regulatory Affairs Specialist and a skilled professional with diverse experience in RA, publishing, client relationship, operations, and training/mentoring. With a decade of exposure to the NMPA guidelines, she is proficient in supervising all Regulatory activities, including IND/NDA/ANDA/BLA submissions, post-approval compliance, labeling, and advertising.

Location

No.99-OL-10-202105025, West section, Hupan Road, Xinglong Street, Tianfu New District, China (Sichuan) Pilot Free Trade Zone

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