Strategic Support When You Need it Most
We offer a comprehensive service that helps pharmaceutical, biotech, and medical device companies ensure their advertising and promotional materials comply with all FDA requirements—so you avoid Untitled or Warning Letters.
- Warning Letter & Untitled Letter Remediation: rapid response strategy, corrective action planning, and remediation support for companies already facing FDA enforcement, with long-term improvements to reduce future risk.
- Promotional Material Review: comprehensive review of ads, websites, digital campaigns, sales aids, and brochures to ensure claims are fully supported, safety information is properly balanced, and risk disclosures meet FDA standards.
- Regulatory, Medical, and Legal Review (MLR/PRC Support): end-to-end support for your Promotional Review Committee or MLR process, including content evaluation for accuracy, evidence standards, benefit–risk balance, and appropriate disclaimers.
- Labeling and Advertising Alignment: expert guidance to ensure promotional materials are consistent with approved labeling, avoiding off-label promotion, and avoid potentially deceptive claims.
- Regulatory Strategy & Submission Services: advice on FDA advertising regulations, OPDP guidance, and industry codes, plus assistance with FDA submissions required to maintain compliance.
.png?width=310&height=439&name=Global%20MLR%20Review%20(RS).png)
Simplifying Global MLR Review: Local Expertise at a Global Scale
Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
News & Insights
September 18, 2025
How to Select the "Right" CMO Partner
Learn how to select the right CMO partner for your company's needs with ProPharma's CMO Compass tool. Avoid delays and regulatory issues by following a systematic selection process.
September 17, 2025
Decoding FDA’s Recent Advertising Enforcement Actions
Key takeaways from FDA’s latest enforcement letters which mark a major shift in advertising oversight and highlight new compliance risks for Sponsors.
September 10, 2025
FDA Launches Crackdown on Deceptive Drug Advertising
FDA’s new crackdown on deceptive drug advertising reshapes pharma marketing. Discover implications for sponsors, compliance strategies, and patient trust.
News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
