Season's Greetings from ProPharma! As the year draws to a close, we want to take a moment to express our heartfelt appreciation to our clients, partners, and colleagues. This season is one of reflection, gratitude, and connection. We are thankful for your trust, collaboration, and dedication throughout the year. We hope this time brings you joy, peace, and moments with those who matter most. At ProPharma, we’re proud of the work we’ve accomplished together and look forward to achieving even greater successes in the year ahead. Wishing you a happy holiday season and a prosperous New Year from all of us at ProPharma! #WeAreProPharma
ProPharma
Business Consulting and Services
Raleigh, North Carolina 136,609 followers
End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
About us
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies. With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science!
- Website
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http://www.propharmagroup.com
External link for ProPharma
- Industry
- Business Consulting and Services
- Company size
- 5,001-10,000 employees
- Headquarters
- Raleigh, North Carolina
- Type
- Privately Held
- Founded
- 2001
- Specialties
- Compliance & Quality Assurance, Commissioning & Qualification, Product Lifecycle Management, Medical Information, Pharmacovigilance, Computer Systems Validation, Process Validation, Cleaning Validation, Technology Transfer, CMO Selection, Process Optimization, Clinical Safety, Regulatory Affairs, PAI Readiness, biopharmaceutical, Life sciences, and regulatory
Locations
Employees at ProPharma
Updates
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We are honored! Thank you, European Contact Centre & Customer Service Awards (ECCCSA)! #WeAreProPharma
We would like to take this opportunity to congratulate ProPharma on their Silver win for ‘Greatest Impact of AI (In-house)’ at the European Contact Centre & Customer Service Awards last month! Congratulations to the team. #ecccsa
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Are you headed to San Francisco for the J.P. Morgan Healthcare Conference? We want to meet with you. Throughout the week of January 13-16, our leadership team will attend JP Morgan and will be available to discuss how to move your product through drug development to regulatory approval, assure compliance with applicable FDA/EMA/global regulatory guidelines, and answer any questions you may have. Whether you are approaching your initial regulatory interactions, a marketing application, or commercial-stage lifecycle management and compliance, we can help. Contact us today to schedule a time to meet with our regulatory experts.
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A well-designed Risk Evaluation and Mitigation Strategy (REMS) isn’t just a requirement — it’s essential for patient safety and regulatory success. Navigating REMS can be complex, but with the right steps, you can build a program that protects patients *and* ensures compliance. Our latest blog offers a practical checklist to guide you through the process, helping you: 🔹 Identify key risks 🔹 Develop effective mitigation strategies 🔹 Align with FDA expectations Ready to simplify your REMS program? Check out the full checklist here: https://lnkd.in/eZVtPAQc.
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The European Health Technology Assessment Regulation (HTAR) is set to transform market access across the EU. Our white paper offers a comprehensive guide to navigating these changes, ensuring your product launch is both compliant and successful. Equip your team with the knowledge to navigate the evolving European regulatory landscape adeptly. Download the whitepaper: https://lnkd.in/e6uKdKUN.
Implementation of the New European Health Technology Assessment Regulation (HTAR) - ProPharma
propharmagroup.com
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Clinical data is the cornerstone of medical device approval. Are you collecting the right data to meet regulatory standards and ensure market success? Navigating clinical data requirements can be challenging, but with the right approach, you can streamline approvals and ensure patient safety. Explore key strategies for collecting, analyzing, and leveraging clinical data effectively. Your path to successful medical device approval starts here: https://lnkd.in/e9URrEk5!
Clinical Data for Medical Device Approval: Navigating the Regulatory Maze
propharmagroup.com
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AI and advanced automation are reshaping clinical trials — and ProPharma is at the forefront of this transformation. In a recent article with Applied Clinical Trials Magazine, our Chief Information Officer, Kirk Wroblewski, shares insights on how AI-driven technologies enhance trial efficiency, improve data accuracy, and accelerate timelines. Learn how ProPharma is leveraging these innovations to drive smarter, faster, and more effective clinical trials. Read the full article here: https://lnkd.in/dNv48tFH. #ClinicalTrials #AI #WeAreProPharma
Applied AI and Advanced Automation in Clinical Trials
appliedclinicaltrialsonline.com
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From detecting adverse events to managing data and ensuring compliance, we know the hurdles are real. We want to hear from you! Cast your vote below in our #ProPharmaPolls. #PharmaInsights
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Unlocking the Safety Code: Understanding #PSUR and #PBRER Navigate these critical safety evaluations' complexities, standards, and regulatory updates. Stay informed, stay vigilant, and ensure compliance Learn more here: https://lnkd.in/eSwGQTpG.
Demystifying PSURs and PBRERs: Ensuring Medicinal Product Safety
propharmagroup.com
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Reflecting on the wonderful past few days spent with ProPharma's President of PV Laura Hopper and Director of PV Client Services Keith Parrell. It is not often that they are able to come out to West Coast to visit and it was a real treat to have them here to bring tremendous value to our visits with various current and prospective PV clients throughout the San Diego area. Thank you both for making the long trip out to San Diego!!! #WeAreProPharma