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Regulatory Affairs

Looking to obtain regulatory approval from the National Medical Products Administration (NMPA)?

With projections predicting China to be the largest Pharmaceutical market in the world by 2020*, the reasons to approach China are abundant. However, the tremendous opportunities for any healthcare company in China are matched only by its complexity and associated risks. That is why it is imperative you have a partner with a proven track record who understands these obstacles and can help you create a strategy that will optimize efforts and maximize success.

R&G has been assisting Sponsors with registration services for nearly a decade. Our colleagues have experience supporting regulatory submissions for a wide-variety of products and can act as your independent regulatory liaison with the NMPA. Over the past five years, our team has consistently broken delivery deadlines at an average rate of 16%, saving a total of 332 months for our clients. In the field of cancer drug, rare disease drug and cell therapy, we have also made outstanding achievements, helping our customers obtain a series of challenging registration results, such as clinical exemption, PK exemption and conditional approval.

Understanding the complexities surrounding the China regulatory requirements and how to implement workarounds plays a critical role in the development of new drugs, generic products, and medical devices。 At R&G we understand how China’s regulations differ from other regulatory bodies, and can give you the support you need to gain approval for your product in China。 If you already have a presence in China, we can act as an extension of your team to get your product to market faster and help maintain it better。

Our team has established a strong partnership with NMPA, and can provide you with the opportunity to communicate and consult directly with NMPA. They can be insightful in changing regulatory conditions and guide you how to pass through NMPA’s regulatory requirements.

From product development strategy for your entire pipeline, through every phase of clinical development, to the maintenance of a successfully marketed product, access to high quality regulatory advice and competent support is critical to the success of healthcare companies of all shapes and sizes。

We support every element of regulatory services with panel members from our Advisory Board and networks comprised of over 60 ex-CDE, ex-CFDA and industry experts。

Product Types:

Drugs (incl。 OTC), Biologics, Botanical drugs, Medical Device and IVD。

Our Regulatory Services include:

  • Regulatory Strategy Consultation
  • Gap Analysis
  • IND, CTA review, preparation and submission
  • NDA, ANDA review, preparation and submission
  • Pre-IND, Pre-NDA meetings
  • OTC Switch Application
  • Clinical Trial Waiver (CTW) Application
  • Medical Device Registration
  • IVD Registration
  • Clinical Evaluation Report preparation
  • Innovative Medical Device Application
  • Supplements/variations and Renewals
  • Importation and exportation Permit Application
  • Facilitation of the review process and NMPA meeting
  • Monthly reports on health and environmental requirements, including the impact on the customer-tailor area

USA FDA Registration

Starting from June 2018, in response to the environmental changes of domestic regulations and the development needs of domestic innovative pharmaceutical enterprises and generic drug enterprises, R&G's Registration Affairs begins to provide services for domestic high-quality pharmaceutical enterprises to apply for USA FDA registration.

The USA FDA registration team is led by senior ex-FDA experts including Dr. Chen Gang and Dr. He Kun. The team will provide all-round services for domestic pharmaceutical enterprises from pre-IND to IND/ANDA/NDA/BLA declaration.

If you would like to learn more about R&G, please download our brochure or feel free to contact us directly.

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