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Regulatory Affairs

Looking to obtain regulatory approval from the China Food and Drug Administration (CFDA)??

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 CFDA. Over the past 5 years our team has consecutively beaten benchmark submission timelines by an average of ~16%., saving our clients and accumulated 332 months!

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 local team has established a strong working relationship with the CFDA and can assist you to open up a line of communication for direct consultation. They can provide insight on how to navigate the ever-evolving regulatory environment and guide you through the CFDA regulatory processes from start to finish.

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 Devices’ 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 CFDA meeting
  • Monthly reports on health and environmental requirements, including the impact on the customer-tailor area

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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