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Preclinical Research
Preclinical Research

IND Filings

Medicilon offers integrated preclinical R&D services, including chemistry, biology, pharmacodynamics evaluation, pharmacokinetics evaluation, and toxicology evaluation. Featuring responsive, timely project management and favorable prices, our integrated services promise quick and smooth project implementation.

Medicilon diamond icon.pngThe investigational new drug (IND) filing service platform
  • Our IND filing service platform features a deep understanding of the registration laws, policies, and relevant technical requirements for chemical drugs in China, the U.S., Australia and the European Union (EU), and thus can provide domestic and foreign clients with services that include consultation on drug development and registration strategies, IND tests based on NMPA and FDA and materials preparation, and submission and approval for abbreviated new drug applications (ANDAs).
    Medicilon also has professional IND and ANDA technical research teams providing one-stop clinical research and project management services throughout the entire process to registration.
Medicilon diamond icon.pngIND filing services
  • NMPA Registrations & FilingsApplication and guidance for CDE communications and exchange meetings IND/ANDA Enabling to NMPAIND Enabling to FDA IND Enabling to TGAonsultation and strategic planningDrug filing Full filing management and trackingProject management services (for clients who choose our preclinical research services only)
    Before the submission of filing materials, Medicilon’s Filing Department will organize internal technical communication meetings to analyze the relevant items to be filed. After the submission of filing materials, a representative in charge of the application will be appointed to ensure continuous communication with the regulatory authorities, following up the filing processes until such filing is completed.
Medicilon diamond icon.pngOur strengths in IND filings
  • Our team is proficient with review concepts and NMPA/FDA regulatory requirements, and t is capable of solve problems with advanced technologies and effective management skills, as well as smooth communication. NMPA and FDA review professionals offer targeted suggestions regarding technology, regulations, and filing strategies. Professional IND and ANDA technical research teams provide one-stop research and project management service throughout the entire filing process . A comprehensive understanding of the latest policies, regulations and industrial trends so to facilitate accurate and quick application submission. Expertise in registration.
    Our IND filing service platform provides our clients with practical registration strategies, as well as ways to avoid potential registration risks and ensure timely and accurate submission of filing materials then track review progress.
Medicilon diamond icon.pngProjects independently filed by Medicilon regarding preclinical research:
  • Since 2015, a total of 165 IND filing projects have been approved by CFDA/NMPA for clinical trials. With Medicilon’s assistance, five innovative drug projects have been approved by FDA and two by TGA Australia for clinical trials.