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Regulatory Submission & Approval

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Overview

Under the leadership of experts with years of experience in registration management, the Regulatory Affairs Department is composed of dozens of senior registration personnel with rich experience in registration. Tigermed RA are familiar to the domestic and international registration laws and regulations, and can provide you with feasible strategies and act as liaison with various regulatory agencies, both on technical and regulatory issues.

 

Features and Advantages

  • The experienced PM will advise the sponsor from the perspective of professional registration regulations and practical experience, ranging from strategic advice and project management to data review and writing, all in compliance with the uniform SOP procedures.
  • Internal supervision and control from PD with abundant project experience ensure the project quality.
  • Considerable number of ongoing projects enable Tigermed RA team to receive the first-hand information and the up-to-date regulatory trends from the drug authorities.
  • One-stop Project Management with interdisciplinary team setting is time-saving and flexible. RA PM seamlessly coordinates information between different sectors.
  • Great expertise on regulatory filing of both domestic & imported innovative drug.

 

Registration of Drug Products in China

  • Acting as Health Authority liaison
  • Feasibility assessment for domestic registration
  • Reviewing and providing guidance for improving the registration dossier
  • Compilation (including translation) and submission of the registration dossier
  • Reviewing specifications
  • Tracking during the registration process

 

Registration of Drug Products in Europe, US, and Australia

  • Act as a liaison to Health Authorities in the US, Europe and Australia
  • Feasibility assessment and registration planning for registration of drug products
  • Preparation and filing of DMFs for APIs
  • Providing guidance on R&D for registration of drug products and reviewing of the dossier

 

Establishing Connections for Clinical Trials

  • Preparation and reviewing of registration dossier for drug products, conversion to eCTD format and submission
  • Tracking registration review

 

Registration of Health Foods in China

  • Imported and domestic health foods
  • Technology transfer and technical changes in health food dossier
  • New food raw materials

 

Registration of Medical Devices

  • Domestic and overseas medical devices and relevant clinical trial
  • Domestic and overseas IVD reagents and relevant clinical trials
  • FDA 510(K) Certification of medical devices
  • EU-CE certification of medical devices

 

Registration of Imported/Domestic Cosmetics

  • Filing of the license application for imported cosmetics
  • Filing of the license application for domestic cosmetics for non-special uses
  • Filing of the license application for domestic cosmetics for special uses

Project Experience

*As of Q1 2020

Updated to July 2019, Tigermed RA team have gained drug registration experiences from 418 projects (including drug and biological). Among these projects, when divided by drug therapy, 94% are indicated for non -tumor indications while 6% (25) are indicated for tumor indications.

Drug registration projects