IND Filings

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The 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 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.

IND filing services

• NMPA Registrations & FilingsApplication and guidance for CDE communications and exchange meetings IND/ANDA Enabling to NMPAIND Enabling to FDA IND Enabling to TGAconsultation and strategic planning to support Drug filingFull filing management and trackingProject management services (for clients who choose our preclinical research services.)
  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 successfully completed.

Our strengths in IND filings

• Our team is expert in review concepts and NMPA/FDA regulatory requirements, and is capable of problem solving with advanced technologies and effective management skills, as well as clear 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 to facilitate accurate and rapid submissions.
  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.

Projects independently filed by Medicilon regarding preclinical research:

• Since 2015, Medicilon has supported 330 IND filing projects approved by CFDA/NMPA, FDA, and TGA for clinical trials.
  In 2022，97 projects have been approved for entering clinical trials by the US FDA and Australia TGA, and 12 projects have been approved for entering clinical trials by NMPA.

Service Cases

FAQs

• What In Vivo PK Tests Should be Completed Before IND Filing in China?

  (1) BA development and methodology verification;

  (2) Conventional PK test;

  (3) Tissue distribution;

  (4) Excretion Research (Material Balance).

Relevant laboratories

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