Regulatory Affairs, North America, Inc.
Durham, United States (US) · Health and Medical
Do your work at Regulatory Affairs, North America, Inc.?
Claim this profile to manage your company.
Verified by Enterprise League
Data quality
Complete · Accuracy
Last verified
May 2026
#pre-ind - ind advice
#preparation
#meetings
#strategic planning
#submissions content evaluation
#development advice for products regulated by fda
#505(b)(2) ndas
Overview
We help clients successfully launch new products in North America by providing expert guidance on pre-IND and IND submissions, strategic planning, and content evaluation. Our team possesses a deep understanding of 505(b)(2) NDAs and development advice for products regulated by the FDA.
With over 25 years of experience (founded in 1997), we’ve built a reputation for meticulous attention to detail and proactive problem-solving, saving our clients significant time and resources. We are dedicated to ensuring regulatory compliance and accelerating product approvals.
We serve a range of clients, from emerging biotech startups to established pharmaceutical manufacturers, providing tailored solutions to meet their specific needs.
Our expertise in regulatory affairs, combined with our commitment to client success, makes us a trusted partner in the pharmaceutical industry.
Contact Details
Durham, United States (US), P.O. Box 52587
Founded
1997
Company Type
Private Limited Company
Employees
2-10
Categories
Keywords
#pre-ind - ind advice
#preparation
#meetings
#strategic planning
#submissions content evaluation
#development advice for products regulated by fda
#505(b)(2) ndas
Listings
Services
Companies teams usually look at after Regulatory Affairs, North America, Inc.
Comparing a few options usually leads to better decisions
Save companies to compare later. Useful when sharing options with your team
This is how your company profile looks to others.