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Preclinical Clinical trial Related services Registration and Regulations
 
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Tigermed Regulatory Affairs Department consists of Drug Registration Division and Medical Device Registration Division, offering customized regulatory services for pharmaceuticals, biological products, and medical devices. Our regulatory experts have decades of experience with SFDA and are very familiar with local regulatory requirements, they can provide you with feasible strategies and facilitate your communication with various regulatory agencies, both on technical and regulatory issues.


Services Scope

Regulatory Scenario Map Out, Gap and Feasibility Analysis
Medical Translation
Documents Sorting and Submission
Sample Testing Arrangement

IND & NDA Tracking

 

Introduction to the Contents of Registration Services:
The Registration Department of TigerMed Consulting is composed of the Drug Product Team, the Medical Device Team, the Health Food Team, and the Cosmetics Team. Our registration experts have more than ten years of experience in registration management. They are the thorough masters of relevant domestic and overseas regulations, and are able to provide practicable registration services for domestic and overseas registration of drug products, medical devices, health foods and cosmetics. During the process of product registration, rich practical experience also enables TigerMed to fully understand the key points for product registration with every authority and also specific requirements for the application dossiers and to keep effective bilateral communication with the client and the regulatory authority in multiple levels and multiple aspects ranging from procedural provisions, regulatory requirements to technical compliance, etc, so as to ensure fast and smooth progressing of the project.
                                                     
Service Scope
I.Registration of Drug Products in China

• Providing the role of registration agent
Assessment of feasibility for domestic registration
• Reviewing and providing guidance for improving the registration dossier;
Compilation (including translation) and submission of registration dossier
• Reviewing of specifications
• Tracking during the whole process of registration

II.Registration of Drug Products in Europe, America, and Australia
Providing the role of US and Australian registration agent
Establishing the drug registration agent system and providing the role of registration agent
Feasibility assessment and registration planning for registration of drug products
Preparation and filing of DMFs for APIs
CEP certificate application for APIs and change applications
Preparation and filing of DMFs and EDMFS for pharmaceutical excipients
Preparation and filing of DMFs and EDMFS for pharmaceutical packaging materials
Providing guidance on R&D for registration of drug products and reviewing of dossier
Establishing connections for clinical trials and reviewing of protocols and reports for clinical trials
Preparation and reviewing of registration dossier for drug products, conversion to eCTD format and submission
Tracking of registration reviewing

III.Registration of Health Foods in China
Registration of imported and domestic health foods
Registration of technology transfer and technical changes of health foods
Registration of new food raw materials

IV.Registration of Medical Devices
Registration of domestic and overseas medical devices and relevant clinical trials
Registration of domestic and overseas IVD reagents and relevant clinical trials
FDA 510(K) Certification of medical devices
EU-CE certification of medical devices

V.Registration of Imported/Domestic Cosmetics
Filing and license application of imported cosmetics
Filing of domestic cosmetics for non-special uses
License application of domestic cosmetics for special uses