Correg, pronounced courage, Consulting offers exceptional contract regulatory affairs services for the pharmaceutical industry.

 

Correg Consulting provides regulatory strategic advice and support for investigational drug development from early to late-phase clinical studies through to marketing applications. We also provide medical and technical writing for clinical, nonclinical, and quality sections of applications and other correspondences with the FDA. 

 

List of services:

 

• Regulatory strategy

• US Agent

• IND support 

• NDA/BLA support

• 505(b)(2) NDA support

• ANDA support

• Clinical summaries and Clinical Study Reports

• Nonclinical summaries

• Quality Overall Summary

• Expedited programs (Fast Track, Breakthrough Therapy, RMAT designations)

• Pediatric programs (Pediatric Study Plan, Paediatric Investigation Plan)

• Rare disease programs (Orphan designation)

• Drug Master File annual report

• IND Annual Report/Development Safety Update Report

• FDA meeting support

• Safety (MedWatch) reports

• Labeling (package insert/SPL, container labels)

• Proprietary names

• OPDP submissions

• Gap analyses

• Regulatory intelligence

 

For inquiries, please send an email to info@corregllc.com.

 

Correg Consulting is a Limited Liability Company formed in California.

 

 

 

 

© 2022 Correg Consulting, LLC