Dosage Form Development Regulatory Affairs
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
Submission application preparation
FDA meeting participation
Drug product guidance at all stages of development
Copyright | Privacy
8810 Rehco Road, Suite F, San Diego, CA 92121
Tel (858) 623-1520 Fax (858) 623-1525
Pharmaceutical product services specializing in formulation
development, cGMP manufacturing and consulting
related to the drug development process.