Allied Regulatory Consulting has been supporting the pharmaceutical industry since 1995. Our team is comprised of seasoned veterans, all located in the United States, who have come together to provide regulatory affairs consulting excellence to companies of all sizes, from start-up to Fortune 500 industry leaders.
With a broad range of expertise, from prescription and OTC drugs to medical devices, cosmetics and dietary supplements, we have all of your needs covered to help get your products from development to launch as soon as possible, while meeting all applicable FDA (and FTC) regulations.
Interested in developing a 510(k) or pursing an Rx-to-OTC switch? We can provide everything you need. When we partner with your company, we will tailor a service package to meet your needs, serving as a sounding board or leading the development of regulatory affairs strategies and documentation. Our team has authored hundreds of NDA, PMA, 510(k), IND and IDE submissions and supplements and we are confident that our experience will shine from the very first interaction.
The "allied" in our name comes from the fact that we also offer additional support including clinical science expertise, biostatics, electronic publishing, project management, medical, manufacturing and design, marketing, quality and even legal services.
The ARC team includes:
With a broad range of expertise, from prescription and OTC drugs to medical devices, cosmetics and dietary supplements, we have all of your needs covered to help get your products from development to launch as soon as possible, while meeting all applicable FDA (and FTC) regulations.
Interested in developing a 510(k) or pursing an Rx-to-OTC switch? We can provide everything you need. When we partner with your company, we will tailor a service package to meet your needs, serving as a sounding board or leading the development of regulatory affairs strategies and documentation. Our team has authored hundreds of NDA, PMA, 510(k), IND and IDE submissions and supplements and we are confident that our experience will shine from the very first interaction.
The "allied" in our name comes from the fact that we also offer additional support including clinical science expertise, biostatics, electronic publishing, project management, medical, manufacturing and design, marketing, quality and even legal services.
The ARC team includes:
- Experts in FDA Strategy Development
- Technical Writers and Submission Authors
- Clinical Study Designers
- Biostatisticians
- Software Engineers
- Marketing Claim Development
- Social Media Drivers
- Advertising and Promotional Material Reviewers
- Medical Affairs Support
Allied Regulatory Affairs Consulting - Providing professional regulatory affairs consulting services at affordable rates for almost 20 years.