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 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...
Navigating EMA and Global Regulations for Medical Information Services
Medical Information services are essential to ensure healthcare professionals (HCPs), patients, and regulatory bodies receive accurate, timely, and compliant information. From managing inquiries to medical writing and clinical trial support, these services are foundational to patient safety and...
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.
From Drafts to First Patient in Record Time
Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning, and smart tools ensured on-time site activation and patient enrollment across multiple regions,...
.png)
FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission
A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory success. The Pre-IND meeting—while technically optional—is a powerful opportunity to align with FDA on...
Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina
Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch risks. Through local expertise, proactive coordination, and fast-tracked approvals, Clinres ensured...
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.