Thought Leadership
ProPharma’s team of dedicated experts provides strategic guidance across the entire product lifecycle, helping pharmaceutical, biotechnology, and medical device companies navigate complex challenges with confidence. By leveraging deep industry expertise and data-driven insights, we deliver tailored solutions that support regulatory compliance, clinical development, and patient safety.
Understanding PADER: A Key Pharmacovigilance Requirement for the U.S. Market
Pharmacovigilance is a global responsibility, and regulatory requirements may differ significantly depending on the region. One such region-specific requirement is the Periodic Adverse Drug Experience Report (PADER), a post-marketing safety report mandated by the U.S. Food and Drug Administration...
Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)
In today’s stringent regulatory landscape, the effectiveness of a pharmaceutical company’s pharmacovigilance (PV) system is supported by three key pillars: the Qualified Person for Pharmacovigilance (QPPV), the Local Person for Pharmacovigilance (LPPV), and the Pharmacovigilance System Master File...
FDA Publishes over 200 Complete Response Letters (CRLs)
On July 10th, 2025, the FDA announced its decision to publish over 200 Complete Response Letters (CRLs) issued between 2020 and 2024. This decision marks a seismic shift in the way our industry approaches regulatory challenges. This bold move lifts the veil on the roadblocks that have historically...
Resources
ProPharma is committed to delivering dynamic research and perspectives crafted by world-class subject matter experts. ProPharma provides valuable insights to its clients to enable thoughtful decision making, as well as informed resource & investment allocation.
Successfully Executing a Tech Transfer in a Week
Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols, dry runs, and full staff training. Equipment, materials, and personnel moved flawlessly with zero...
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Obesity – Accelerated Timelines
A mid-size biotech needed fast U.S. market entry for an obesity trial. ProPharma activated 20 sites in 30 days and enrolled 300+ patients—meeting goals despite an increased sample size. Strategic staffing, patient support, and at-home dosing training ensured compliance and retention, making this...
Key Compliance Challenges in U.S. Medical Information Services
For Medical Information (MI) teams navigating today’s evolving regulatory landscape, compliance isn’t just a requirement — it’s a strategic imperative. From managing off-label inquiries to integrating AI tools and overseeing third-party vendors, the stakes for getting it right have never been...
Press Room
ProPharma is at the forefront of the life sciences industry and continues to innovate and elevate its position as a pharmaceutical and MedTech service provider. Stay up to date on ProPharma's latest news and most recent announcements.
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review
New hire elevates strategic labeling solutions to support faster approval and smarter commercialization. RALEIGH, July 8, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment...
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma Wins Silver at ECCCSA for AI Innovation in Medical Information RALEIGH, NC, January 31, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, has been awarded Silver in the "Greatest Impact of AI (In-house)" category...
ProPharma Appoints Brian Tuttle as Chief Financial Officer
Seasoned Life Sciences Executive to Spearhead Financial Strategy and Drive Accelerated Growth. Raleigh, NC, October 21, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment...
Awards
With over 20 years of proven success, ProPharma continues to be acknowledged within the life sciences industry for providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma proudly shares its recognition and achievements as its team works to improve the health and safety of patients.
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review
New hire elevates strategic labeling solutions to support faster approval and smarter commercialization. RALEIGH, July 8, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment...
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma Wins Silver at ECCCSA for AI Innovation in Medical Information RALEIGH, NC, January 31, 2025 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, has been awarded Silver in the "Greatest Impact of AI (In-house)" category...
ProPharma Appoints Brian Tuttle as Chief Financial Officer
Seasoned Life Sciences Executive to Spearhead Financial Strategy and Drive Accelerated Growth. Raleigh, NC, October 21, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment...
Events
ProPharma is committed to engaging with both existing and prospective clients at the right time and in the right place. Speak with a member of the team at one of these upcoming events.
Overcoming Challenges. Advancing Patient Care.
Bringing new therapies to market is more complex than ever. ProPharma helps you navigate regulatory challenges with expert guidance, ensuring compliance and accelerating patient access to life-changing treatments.