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.
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,...
The Joint Commission Adds Pharmacists to Survey Teams: A Step Towards Comprehensive Healthcare Quality
In recent years, healthcare has undergone rapid transformation, especially in how care is delivered, measured, and improved. One of the most significant players in ensuring quality healthcare delivery is The Joint Commission (TJC). This nonprofit organization accredits and certifies healthcare...
FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program Overview
An inside look at FDA's new Commissioner's National Priority Voucher (CNPV) pilot program—what it is, why it matters, and how regulatory and development teams can leverage it to accelerate high-priority therapies. Racing for Cures: How FDA's New Pilot Program Will Accelerate Drug Reviews On June...
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.
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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...
Rapid Safety Database Implementation: Achieving Global Compliance in Just Four Weeks
A U.S. pharmaceutical firm needed a global safety database live in four weeks, handling 4,000 legacy cases and active trials. ProPharma delivered a fully configured solution using tailored data conversion methods, including CIOMS to XML. All legacy data was successfully tested and loaded, the team...
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 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...
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
Regulatory and Compliance excellence recognized for innovation across the product development lifecycle RALEIGH, NC, October 9, 2024: ProPharma, a leading global provider of regulatory, clinical, and compliance services for the life sciences industry, is pleased to announce it has won the...
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 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...
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
Regulatory and Compliance excellence recognized for innovation across the product development lifecycle RALEIGH, NC, October 9, 2024: ProPharma, a leading global provider of regulatory, clinical, and compliance services for the life sciences industry, is pleased to announce it has won the...
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.