Service Platform for Investigational New Drug Application (IND)
Based on its in-depth understanding of relevant regulatory requirements and technical requirements for chemical drugs of China and the United States, the IND Service Platform is cable of providing CFDA IND application and USFDA IND/ANDAapplication services to the domestic customers, and providing CFDA IND/ANDAapplication service to foreign customers.
Our clients include those who authorize the full pre-clinical research to be carried outin Huahai, and those who seek only the clinical registration service.
Clinical Registration Application ServicesPrepare and submit CFDA IND documents for domestic customers.
Submit USFDA IND/ANDA documents on behalf of the domestic clients;
Submit CFDA IND/ANDA documents on behalf of the foreign customers.
Project Management ServicesReview, organize and perform technical evaluation to the IND/ANDA filings of theclients’; and edit, review and finalize the documents.
Prior to filing submission, the Registration Department of Huahai Pharmaceuticalorganizes an internal technical review, performing a detailed analysis of the project.Post the submission of the filing, an experienced project manager keeps timelycommunication with the regulatory authorities, and tracks the progress in real time tillthe successful application.
The Advantages of the IND Service Platform of Huahai PharmaceuticalBeing equipped with an experienced IND & ANDA research team, we provideone-stop service including research, and end-to-end project management andapplication services.Being equipped with a rich resource of review experts, we provide targeted technical,regulatory, and filing strategy recommendations.
The IND Service Platform of Huahai Pharmaceutical customizes a feasibleregistration strategy for its clients, avoiding potential registration risks and ensuringtimely submission of application materials per the requirements, and tracks theprogress of the review, to support its clients to complete the registration reviewprocess quickly.
API INDThe API IND team of Huahai Pharmaceutical has more than 20 years’ domesticand international registration experience. The team is familiar with the nationalregistration process and has up-to-date knowledge of the latest laws and regulations. Itprovides professional and efficient services including project research, documentpreparation, submission, eCTD format conversion, response to defect letter and daily maintenance of the documents. The specific services to its clients include theregistration of Chinese electronic data, US DMF document preparation, theregistration application for European CEP/COS, EMA, ASMF, eCTD submission,Japanese login and registration, and Korean registration application, etc.