Regulatory Affairs
lmport/Domestic Registered Agent
Registration Strategy Plannin and Legal Technical Consultation
Relying on the Yeedo's core technical team and consulting team's in-depth understanding of the technical regulations of drug registration, to ensure compliance with requirementsof drug and device registration
Regulatory Affairs
For all kinds of registration applications (such as clinical trial applications, marketing authorization applications, supplementary applications, etc.) and other registration-related matters (such as API registration and filing) stipulated in the “Provisions for Drug Registration”,we provide registration related transaction services for customers. The specific services include but are not limited to gap analysis, agency meeting, documents collation, application submission, site inspection,QCDE quality test and review and approval progress tracking, etc.
One-stop RA services for import & domestic Products
Relying on strong management teams and professional consultants, we have deep understanding on regulations affairs, ensuring that the entire project is in line with Chinese drug registration requirements.
Technical Evaluation Services
In accordance with the relevant technical guidance and requirements of China's drug registration, and in combination with the review principles and processing scales of CDE at the current stage. Conduct a comprehensive and in-depth evaluation of the scientificity and technical conformity of the research plan, research results or registration application materials provided by the customer, so as to avoid the risk of "no approval" and reduce the frequency of supplementary materials submission and shorten the period of registration application.
RA/Technology Consulting Services
RA Consulting Services - Provide clients with the interpretation of the background, connotation, applicable situation and consulting reports or corresponding suggestions based on the Chinese laws and regulations on drug supervision and the departmental rules and working documents issued by the Drug Regulatory Administrations with or without the specific varieties.
Technical Consulting Services - Provide clients with the interpretation of the background, connotation, applicable situation and consulting reports or corresponding suggestions based on the guidance and technical requirements related to drug R&D registration issued by Drug Regulatory Administrations at home and abroad and the ICH with or without specific varieties.
RA/Technology Consulting Services
R&D Project Management Services
Provide commissioned R&D or technical support services for customers during the whole process or at a certain stage of R&D of new drugs or generic drugs. According to the requirements of customers, the services may include but are not limited to vendor screening and management, study plan design and evaluation, implementation process management and technical guidance, study data analysis and result evaluation, quality inspection, registration application, etc.
R&D Project Management for New Drugs
Service scope:Covers pharmacy, clinical trials,inspection and evaluation, registration