Regulatory Affairs

R&G can provide a complete registration service system for strategy consulting and regulatory applications of drugs and medical devices in China, the United States, Europe and some Asia-Pacific regions. The domestic registration team of R&G, composed of senior regulatory affairs director (over 10 years of experience) and regulatory affairs experts in chemical drug, biology, pharmacology, toxicology, clinical medicine, QC and others, is a extremely stable and service-oriented registration team with refined and professional management.

Over the past 5 years, the registration service team of R&G has successfully completed more than 170 drug and device registration application projects, especially in innovative drugs and medical devices, using regulations flexibly based on rich practical experience and expert resources to ensure that the registration and clinical development of pharmaceutical products can be effectively and rapidly promoted.

Innovative Drugs

More than 50 IND applications (including antibody drugs, cell therapy, ADC, etc.) have been completed in the last 3 years. Nearly 10 applications for conditional approval for marketing have been successfully supported.

Medical Devices

R&G has successful registration experience in more than 40 devices in implantation, medical beauty, ophthalmology, surgical robots, in vitro diagnostic reagents and others, and applications for innovative medical devices.

Applications in both China and the United States

Nearly 20 US IND applications have been successfully completed or participated in the last 3 years. Nearly 10 drug and device projects have been registered or introduced in Hong Kong and Macao, Guangdong-Hong Kong-Macao Greater Bay Area and Boao Lecheng.

Professional Medical Translation

Covering pharmacy, biology, pharmacology and toxicology, medicine, medical device and related specialties.

eCTD Services

From Word files, PDF format adjustments (including OCRs, internal linkages, bookmarks, etc.), and finally eCTD file package generation and standardization validation.