Regulatory Affairs

With 40 years of regulatory experience throughout the product lifecycle for drugs, devices, OTC, and medical foods, we are immensely qualified to drive the regulatory framework for successful and more rapid approval. We work with you to reduce risk, increase compliance, and improve efficiency.

Our regulatory experts are ready to support your:

Pre-IND/CTA implementation
IND/CTA submission & routine management
Types A, B, C, EOP2 submissions & meetings
ANDS/SNDA submission
OTC, Rx → OTC switch
SPA strategy and submission
Pre-NDA/BLA submission
Peri/Post approval
505(b)(2) strategy development and implementation
GLP Program
GMP Program
Labelling and Risk Management
GRAS/GRASE
Annual Reporting (DSUR, PSUR)
Orphan Drug Designation/Annual Reporting
Global Publishing and eCTD Submissions
ICSR/aggregate PV Reporting