New Drug Development Regulatory Affairs and Strategic Planning

IriSys scientists have worked closely with regulatory agencies to most efficiently and effectively move a drug candidate forward. The major activities include the following.

Regulatory strategic planning
FDA Pre-IND support and preparation
CMC support and preparation
Regulatory reports preparation
Regulatory Agencies communication
FDA meetings

8810 Rehco Road, Suite F, San Diego, CA 92121
Tel (858) 623-1520 Fax (858) 623-1525

Our pharmaceutical product services include preclinical
studies for drug formulation compounds crucial
to the development of the dosage form.