IND Registration and Application
IND (Investigational New Drug): Generally refers to a new drug that has not yet received market approval and is undergoing various stages of clinical trials. It involves submitting an application to regulatory authorities to demonstrate the drug's safety and rationale for conducting clinical trials. Clinical trials can only commence after approval is granted. JOINN Laboratories has a professional technical team with a comprehensive understanding of the relevant laws, regulations, and technical guidelines of China's NMPA, the US FDA, Japan's PMDA, South Korea's MFDS, and the EU's OECD. We provide end-to-end application services for IND submissions to both China's NMPA and the US FDA, helping innovative drug companies save significant time and costs, and facilitating new drug approval.
Service Content
Pharmaceutical (CMC)
Development, production, and quality research of active pharmaceutical ingredients (API) and formulations
Writing and reviewing of pharmaceutical research materials (2.3 Quality Overview and M3 Quality Studies)
Non-Clinical
Pharmacodynamic study
Pharmacokinetic and metabolism studies
Drug safety evaluation
Bioanalysis
Writing non-clinical overviews and summaries (Module 2.4-2.6)
Clinical
Design of clinical protocol and development strategies
Investigator's Brochures (IB) writing
Informed Consent Form (ICF) writing
Risk management plans (RMP) writing
Clinical summaries writing
Registration and Application
Registration strategy analysis and regulatory consulting
Preparation and submission of Pre-IND meeting materials
Preparation and submission of IND registration materials (M1-M5)
Service Advantages
Provide tailored IND application strategies and solutions based on the drug’s characteristics and development stage
Prepare and submit application documents efficiently and accurately, shortening the application cycle and accelerating the IND application process
Maintain close communication to stay updated on review progress and feedback promptly
Professional project management with a track record of over 1000+ IND applications
