Strategic Consulting
Our strategic consulting services allow you to move your product from discovery to market quickly and efficiently. We are experts in strategic product placement issues; can help you utilize expedited development pathways; and develop integrated development plans. Our consultants are experts in developing technical, scientific, and regulatory solutions to even the most complex regulatory issues.
Regulatory Operations
DRA’s regulatory operations group can help you seamlessly write and/or verify all of your regulatory submissions. We offer comprehensive writing services including INDs, CTDs, Pre-IND, EOP2 and pre-NDA meeting packages, IBs, annual reports, orphan drug applications, SPA submissions, and breakthrough therapy designations. Furthermore, we can produce and maintain your submissions electronically or on paper. With our EU partners, we can also provide seamless EU regulatory maintenance.
US Agent
As your US agent, we negotiate with the FDA. We have experience and expertise across all Divisions of CDER and CBER. In addition, we provide guidance on regulatory law and guidance and are up to date on policy changes within the FDA. Our goal is to provide a knowledge based approach to regulatory interactions to streamline development.
[/vc_column_text][/vc_column]
[/vc_row]Regulatory Operations
DRA’s regulatory operations group can help you seamlessly write and/or verify all of your regulatory submissions. We offer comprehensive writing services including INDs, CTDs, Pre-IND, EOP2 and pre-NDA meeting packages, IBs, annual reports, orphan drug applications, SPA submissions, and breakthrough therapy designations. Furthermore, we can produce and maintain your submissions electronically or on paper. With our EU partners, we can also provide seamless EU regulatory maintenance.
US Agent
As your US agent, we negotiate with the FDA. We have experience and expertise across all Divisions of CDER and CBER. In addition, we provide guidance on regulatory law and guidance and are up to date on policy changes within the FDA. Our goal is to provide a knowledge based approach to regulatory interactions to streamline development.