China CRO Company,Preclinical research services

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IND Filing

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Medicilon is the first CRO to offer preclinical animal testing service for the global pharmaceutical companies in China. We provide the IND filing for the preclinical services. Medicilon is the CRO that fulfill both the China and US GLP standards. Medicilon could submit the application for both US FDA and CFDA for your new drug. Since 2004, we have successfully helped our clients to submit their new drug application to US FDA and CFDA and met the requirements of the US FDA and CFDA. We have undergone several inspections and passed all of them. Medicilon will provide an efficient, cost-effective and professional service to help our clients to achieve their goals.


Medicilon’s IND Application Service

With an insight into drug regulatory policy environment of China and the United States, Medicilon's drug registration is able to provide CFDA IND application, USFDA IND / ANDA application services for domestic customers and CFDA IND / ANDA application service for foreign customers.
Medicilon's drug registration group not only provide entire IND filing to our customers but also to provide the clients who only have IND filing requirements.

Medicilon's IND Filling Services

  • Preparation and submission of CFDA IND documents for domestic customers;
  • Proxy of USFDA IND/ANDA documents submission for domestic customers;
  • Proxy of CFDA IND/ANDA documents submission for foreign customers;
  • Project management services (only for customers with complete preclinical study);
  • Review, collation and technical evaluation of the IND / ANDA filing documents provided by the customer; and then complete the preparation, review, editing and finalization;
Before the submission of the application materials, Medicilon's IND application department will organize an internal technical communication meeting about a detailed analysis of the declaration project. After the submission of the application materials, there will be a senior reporting person in charge of the continuous communication with the regulatory body, and ensure a real-time follow-up reporting progress until the declaration of the successful completion.
In addition, according to the recent analysis of domestic drug filing data, the Chinese government will setup some innovative policies which have been evident in the drug declaration. Therefore, it is expected that the innovative drugs in China will have a good momentum of development.

Advantages of IND Application Services

  • A professional IND/ANDA research team can provide one-stop research, full project management and reporting services;
  • Rich knowledge resources of CFDA/USFDA experts can provide targeted technology, regulations, reporting strategy recommendations;

Medicilon's IND application group is leading by our VP and experienced researchers, who dedicate to provide our customers a satisfactory integrated preclinical services.


Service for Complete Preclinical Study and Independent IND Application Project

(The whole set of preclinical studies include: APIs process and quality research, preparation process and quality research, efficacy, drug and safety evaluation)
  • 3 IND Packages Accepted by USFDA
  • 3 IND Packages Accepted by TGA
  • 15 IND Packages Approved by CFDA
  • 10 IND Packages Already Submitted to CFDA


Service for Complete Preclinical Study and Public IND Application Project

(The whole set of preclinical studies include: APIs process and quality research, preparation process and quality research, efficacy, drug and safety evaluation)
  • FZ016, chemical medicine category 1, planned CFDA and USFDA IND declaration, already got clinical approval of CFDA in August 2016, and will be declared USFDA.
  • X842, chemical medicine category 1, planned CFDA and EMEA and USFDA IND declaration, already submitted EMEA CTA documents in November 2016 and CFDA IND documents in January 2017, and will be declared USFDA.
In order to avoid the risk of registration, Medicilon’s IND filing services customizes a practical registration strategy for customers to ensure a timely and accurate submission of the declaration data, This could help our customers to quickly complete the registration review process.

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