TRI uses a standardized library of document templates, data tools, programs, and processes to produce compliant regulatory submissions from early phase development through the entire life cycle of your investigational product.
- Investigational Product Applications
- Evaluation of preclinical program to support the application
- Pre-Investigational New Drug (IND), Pre-Investigational Device Exemption (IDE), and Pre-New Drug Application (NDA) Briefing Packages
- IND, IDE, NDA, BLA, and PMA, and Correlative Services Worldwide
- Annual Reports and Development Safety Update Reports (DSURs)
- Master Files
- Investigator’s Brochures
- Literature reviews and summaries
- Standard Operating Procedures (SOPs)
In order to make your product available to the public as soon as possible, if applicable we request one of the FDA´s priority designations: Fast Track, Breakthrough Therapy, Accelerated Approval or Priority Review. After the initial IND submission, IND maintenance is equally important. Our regulatory experts prepare Drug Master Files (DMFs) to support IND applications, manage your IND protocol and information amendments, safety reports, and annual reports according to the 21 CFR 312 requirements.