From FDA to CE Marking, navigate regulatory hurdles with ProPharma. Discover how a medical device start-up achieved global market entry in record time. Get your copy today: https://lnkd.in/eMaPyBBD
ProPharma
Unternehmensberatung
Raleigh, North Carolina 125.514 Follower:innen
End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
Info
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
Externer Link zu ProPharma
- Branche
- Unternehmensberatung
- Größe
- 5.001–10.000 Beschäftigte
- Hauptsitz
- Raleigh, North Carolina
- Art
- Privatunternehmen
- Gegründet
- 2001
- Spezialgebiete
- 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 und regulatory
Orte
Beschäftigte von ProPharma
Updates
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I am grateful to have met with our amazing ProPharma team in Hyderabad, India who exemplify patient and customer centricity by delivering outstanding work for our #medicalinformation, #pharmacovigilance #clinicalresearch solutions and #quality and #compliance service lines. India is a very important part of our growth strategy and the amazing success story that ProPharma is. Pavan Kumar HS Naga Mukteswara Rao Meka Pinky Sharma Amol Yelgaonkar Dr. Kiran Kandula Ankur Joshi Thanks so much for the collaboration and hospitality and hope to meet again! #teamworkmakesthedreamwork #india #propharma
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Navigating the new European Health Technology Assessment Regulation (HTAR) is challenging, but ProPharma is here to help you succeed with your European product launch! Initiated in 2021, HTAR is a game-changer for health technology assessments, unifying clinical perspectives across EU member states for medicinal products, IVDs, and high-risk medical devices. Our latest whitepaper delves into key components like Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), which are crucial for your Market Authorization Application (MAA) to the European Medicines Agency. What’s inside: - HTAR implementation timelines - Best practices for preparing your product launch - Strategies to overcome HTAR compliance challenges Stay ahead of the evolving guidelines and ensure your success in the European market. Complete our form for instant access to our comprehensive whitepaper: https://lnkd.in/e6uKdKUN! 📄 #HTAR #EMA #RegulatoryAffairs
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What's your guess? Tap into our #ProPharmaPolls! Learn more: https://lnkd.in/gVn7YVtg
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Discover the power of our global contact center! From multilingual support to 24/7 availability, we ensure seamless service worldwide, tailored to local cultures and regulatory standards. Empower your global outreach today: https://lnkd.in/ehwyeGVA!
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Managing vendor audits efficiently while maintaining compliance can be challenging. Explore how outsourcing can streamline processes and maximize cost efficiency in our insightful blog: https://lnkd.in/eBXdTB-A.
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Every marketing authorization holder (#MAH) needs a robust pharmacovigilance (#PV) system to ensure product safety. This system monitors the safety of medicinal products and detects any changes in their risk-benefit balance. Key components include the Qualified Person for Pharmacovigilance (#QPPV) and Local Persons responsible for Pharmacovigilance (#LPPV). Learn how to navigate the complexities of PV systems and meet regulatory requirements effectively. Read our blog to learn more: https://lnkd.in/e9K_MJnE.
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Cast your vote in this week's poll about Medical Information (MI), and stay informed! https://lnkd.in/gkg-jXcA #ProPharmaPolls #PharmaInsights
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Happy World Social Media Day from ProPharma! 🌐✨ Join us in advancing life sciences through innovation and collaboration. If you're not already, follow us for the latest research, insights, and industry updates! Instagram: @propharma_global Facebook: ProPharma Twitter/X: @ProPharmaGroup #WorldSocialMediaDay #LifeSciences #WeAreProPharma
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ProPharma
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