IriSys’ management has a deep understanding of current regulatory
philosophy and standards and has direct experience in working with
the FDA at all levels. IriSys provides the following services.
Regulatory strategic planning
Product development, processes or procedures evaluation with
regard to regulatory compliance
Pre-IND meeting package preparation for FDA review
CMC section of IND preparation
Data generation
Reports
Submission application preparation
FDA meeting participation
Drug product guidance at all stages
of development
