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.
Medical Information Contact Center: The Silent Revolution
Medical Information Contact Centers have long operated behind the scenes, connecting pharmaceutical companies, healthcare professionals, and patients through phone and email to provide product information and safety support. Today, these centers are undergoing a profound transformation—not just in...
Leveraging Online FDA Information to Accelerate ANDA Timelines
In the race to generic drug approval, timing is everything. Delays in Abbreviated New Drug Application (ANDA) submissions or setbacks during FDA review can mean missed market opportunities, especially in competitive therapeutic areas. For applicants, a key aspect in optimizing timelines lies in the...
Maximizing the Value of FDA Pre-IND Meetings for Successful 505(b)(2) NDA Submissions
For drug developers leveraging the 505(b)(2) pathway, the FDA Pre-Investigational New Drug (Pre-IND) meeting is a strategic opportunity that can shape the trajectory of an entire development program. These early interactions help Sponsors validate regulatory assumptions, align on data requirements,...
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,...
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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.