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| Strategic Regulatory
Services |
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The Regulatory Affairs team at CBR International
Corp. provides strategic regulatory support for the development
of biologics, drugs and devices. Our consultants have a clear
understanding of the requirements for completion of each element
of regulatory submissions to FDA, the EU and other international
agencies.
Regulatory support includes writing and preparing IND, NDA,
BLA and CTD submissions, coordinating and preparing for Agency
meetings, acting as an authorized representative, writing
preclinical protocols and phase I through III protocols, and
advising companies on labeling and packaging. Our Regulatory
team also has extensive knowledge in writing regulatory standard
operating procedures as well as maintaining regulatory files,
databases and archiving for companies without the capability
to store and record all formal documents.
CBR International has been successful in organizing, designing
and submitting clear and concise regulatory submissions to
CBER, CDER and CDRH that exceeded Agency expectations. We
specialize in meeting packages and requests, and preparing
our clients for face-to-face interactions with regulatory
authorities throughout product development. Our staff has
successfully prepared IND applications as well as orphan drug
designation applications and export requests. The team’s
expertise extends to acting as U.S. representative for European
countries as well as training in Good Clinical Practices and
Good Manufacturing Practices. CBR consultants have also been
involved in conducting clinical trials and writing successful
BLAs, CMCs and CTDs.
Our consultants include former FDA reviewers and investigators.
Specifically, Dr. Jeanne M. Novak leads the team as a former
BLA project manager at CBER. At the FDA, Dr. Novak coordinated
plans for the future execution of a common BLA submission
format for all CBER-regulated products. She served as the
primary reviewer for over seventy IND’s and as the regulatory
coordinator for over twenty PLA’s and various labeling
submissions. CBR International has team members with years
of industry and regulatory experience, including members with
RAC certification.
Specific Consulting and Development
Experience
Consistent, thorough and up-to-date analysis of your evolving
needs is just the beginning of our commitment to your program.
For a comprehensive assessment of your program requirements,
please contact us by calling (720) 746-1190 or by email at
info@cbrintl.com.
SOP
Writing • IND Preparation • E-Documentation
• BLA Preparation • FDA Meeting Packages •
NDA Preparation • Orphan Drug Applications •
CTD Preparation • Export Request Documentation •
MCA Filings • CTX Preparation • Meeting Requests
• Regulatory Documentation • QA Review and Sign-Off
• Authorized U.S. Representative • Protocol
Development |
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