Services

Services provided by the drug development and regulatory group will vary according to the individual needs of the investigators. For example, services to help investigators could include:

• Preclinical consultation
  • Develop an IND gap analysis and outline a plan to advance a compound to IND
• Provide preclinical study support
  • Protocol design, and report writing
  • Evaluation of vendors and study monitoring
  • Assessment of qualification of excipients, impurities, extractables and leachables
  • Scientific and regulatory advice
• Provide guidance for CMC activities
  • Drug substance and drug product manufacturing
  • Evaluation of manufacturers
  • Formulation development
  • Scientific and regulatory advice
• Regulatory writing and consulting
  • Preparation of regulatory documents and FDA communications
  • FDA meeting support
  • Pre-Investigational New Drug Application (IND) briefing packages
  • Investigator brochures
  • Scientific and regulatory advice

Requesting support:

• To request RTI support or more information, contact the Clinical Research Compliance Office (CRCO) at This email address is being protected from spambots. You need JavaScript enabled to view it..
• To facilitate the request process, complete the RTI Regulatory Services Request Form (.docx) and submit to the CRCO.