Insights & News
Discover more about ProPharma and how its dedicated team of industry-leading experts supports clients at every step through the product lifecycle.
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.
From Feasibility to First Patient In: Streamlining Study Start‑Up with Confidence
Clinical trial timelines are rarely lost during study conduct but are lost long before the first patient is screened. Delays in study startup often begin at country selection and feasibility where over‑optimistic assumptions, limited site insight, and fragmented planning quietly set the stage for...
QMSR Explained: Key Changes from FDA QSR to the New Quality Management System Regulation
The FDA's transition from the long-standing Quality System Regulation (QSR, 21 CFR Part 820) to the new Quality Management System Regulation (QMSR) represents one of the most significant regulatory shifts in decades. By harmonizing with ISO 13485:2016, the FDA aims to align U.S. requirements more...
Building Relationships with Sites: The Hidden Driver of Faster Start-Ups
Humanized content about engagement strategies with sites and investigators. The Study Start Up (SSU) phase of clinical trials always feels very chaotic when you are in the “thick of it” with feasibility, site list finalization, regulatory body submissions, essential record templates, Client...
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.
Inspection-Ready AI: Building Quality Frameworks That Keep Pace with Innovation
As artificial intelligence becomes increasingly embedded across life sciences, organizations face a growing challenge: ensuring quality and compliance frameworks evolve alongside rapidly advancing technologies. While AI can improve efficiency, scalability, and decision-making, it also introduces...
Ensuring Continuity of Neonatal Vitamin Prophylaxis During a Product Shortage: A Regulatory and Pharmacovigilance-Led Solution
Product shortages involving essential medicines can create significant clinical and regulatory challenges, particularly when vulnerable patient populations depend on uninterrupted access to treatment. Maintaining continuity of care while adhering to strict regulatory requirements requires close...
Meeting Patients Where They Are: Delivering Global Clinical Support for Time-Sensitive Research
Conducting clinical research for rare pediatric populations presents unique operational challenges, particularly when eligible patients may be born anywhere in the world and require immediate identification, screening, and enrollment. Ensuring consistent protocol execution while coordinating care...
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 Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development
New proprietary capability enhances ProPharma's regulatory service delivery model, helping clients accelerate submission development while maintaining the highest standards of quality and compliance. RALEIGH, July 8, 2026 – ProPharma, the leading global provider of regulatory, clinical, and...
ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and HTA Capabilities
ProPharma is excited to welcome Kevin van Dooren as Vice President, Health Economics and Outcomes Research (HEOR) and Market Access, to our Regulatory Sciences team. The addition of Kevin marks a significant step forward in our commitment to delivering fully integrated regulatory and market access...
ProPharma Appoints Adrian Pencak as Chief Commercial Officer
Life Sciences Industry Veteran Appointed to Lead Global Commercial Organization RALEIGH, N.C. – May 27, 2026 – ProPharma, a leading provider of regulatory, clinical, and compliance services for the life sciences industry, today announced the appointment of Adrian Pencak as Chief Commercial Officer....
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 Advances Technology Enablement Strategy with AI-Assisted Capability for ANDA Submission Development
New proprietary capability enhances ProPharma's regulatory service delivery model, helping clients accelerate submission development while maintaining the highest standards of quality and compliance. RALEIGH, July 8, 2026 – ProPharma, the leading global provider of regulatory, clinical, and...
ProPharma Welcomes Kevin van Dooren to Strengthen Integrated EU Regulatory and HTA Capabilities
ProPharma is excited to welcome Kevin van Dooren as Vice President, Health Economics and Outcomes Research (HEOR) and Market Access, to our Regulatory Sciences team. The addition of Kevin marks a significant step forward in our commitment to delivering fully integrated regulatory and market access...
ProPharma Appoints Adrian Pencak as Chief Commercial Officer
Life Sciences Industry Veteran Appointed to Lead Global Commercial Organization RALEIGH, N.C. – May 27, 2026 – ProPharma, a leading provider of regulatory, clinical, and compliance services for the life sciences industry, today announced the appointment of Adrian Pencak as Chief Commercial Officer....
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.