Are you choosing the perfect ELN for your lab? Our blog covers essential considerations, from infrastructure needs to user adoption strategies. Ensure success with expert insights. https://lnkd.in/eK3f6q66 Authors: Warren Antonio Vieira & Claire Hill
ProPharma
Bedrijfsconsulting en -services
Raleigh, North Carolina 125.973 volgers
End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
Over ons
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
Externe link voor ProPharma
- Branche
- Bedrijfsconsulting en -services
- Bedrijfsgrootte
- 5.001 - 10.000 medewerkers
- Hoofdkantoor
- Raleigh, North Carolina
- Type
- Particuliere onderneming
- Opgericht
- 2001
- Specialismen
- 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 en regulatory
Locaties
Medewerkers van ProPharma
Updates
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Learn more about our Advertising & Promotional Review Consulting: https://lnkd.in/e-WUZfUE. Tap into this week's #ProPharmaPoll. #PharmaInsights
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📣 Meet the Expert: Susanna Heinonen, Senior Pharmacovigilance Consultant, QPPV office | EU/UK QPPV, at ProPharma🌟 As EU/UK QPPV, she oversees PV systems, evaluates risk minimization, and collaborates with clients to ensure product safety and compliance. Discover how Susanna and ProPharma’s expert team support global customers with comprehensive pharmacovigilance services. Read more about her: https://lnkd.in/e5CUATzj #MeetTheExpert #WeAreProPharma
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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
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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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ProPharma
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US$ 8.625.166,00