Ensure compliance with local requirements and technical formatting, including specific modules and XML structure by understanding regulatory timelines and getting expert guidance. To know how with the right preparation, navigating NMPA's eCTD system effectively. Contact Freyr Solutions today to learn how we can support your successful market entry in China. https://lnkd.in/gjtPYEAB #ectd #compliance #FreyrSolutions
Freyr Publishing and Submissions
IT Services and IT Consulting
150 College Road West, Ste 102, Princeton NJ 676 followers
eCTD, NeeS, eCTD Conversions, Validation, Publishing.
About us
Freyr assists Life Sciences organizations to streamline the entire Health Authority (HA) submission management process, right from dossier development, submission planning, tracking, publishing, and final submissions to HA including delivery confirmation/acknowledgment, to ensure error-free, timely, and quality submissions throughout the submission lifecycle. With expertise in Regulatory publishing services, Freyr supports paper, electronic, eCTD, and NeeS submission formats. With a flexible publishing and submission software, Freyr SUBMIT, Freyr enables companies to effectively meet all their specific and unique Regulatory submission requirements for faster and more efficient approval of Drugs, Biologics, and Medical Devices by global HAs. Our Vision “To be the essential partner to manage global Regulatory complexity and market safe and compliant products in local countries.” In order to succeed, we must first believe that we can, and we strongly believe the future is not something we enter, it is something we create. And we are here to create a compliant pathway for our customers’ global market entry. Quick Facts: • 250+ Experts • 200+ Customers • 150,000+Total submissions • 25000+ NeeS Submissions • 77000+ LCM eCTD • 400+ MAA Submissions
- Website
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https://www.freyrsolutions.com/regulatory-publishing-and-submissions
External link for Freyr Publishing and Submissions
- Industry
- IT Services and IT Consulting
- Company size
- 1,001-5,000 employees
- Headquarters
- 150 College Road West, Ste 102, Princeton NJ
- Specialties
- publishing and submissions
Updates
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Reduce time, cost, and complexity by consolidating Regulatory submissions for the US, EU, and Japan. Grouped submissions ensure faster approvals, consistent data, and seamless global expansion. Ready to simplify your path to market? Let Freyr guide you through our carousel. #Freyrsolutions #RegulatorySubmissions #GroupedSubmissions
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Ensure compliance with local requirements and technical formatting, including specific modules and XML structure by understanding regulatory timelines and getting expert guidance. To know how with the right preparation, navigating NMPA's eCTD system effectively. Contact Freyr Solutions today to learn how we can support your successful market entry in China. https://lnkd.in/gjtPYEAB
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Complex submission formats, evolving guidelines, and tight timelines can delay your product’s market entry. Through this carousel, let’s get you ready to overcome those hurdles and streamline your submission process. To know more: https://lnkd.in/gVazWrhs #RegulatorySubmissions #eCTD #ComplianceExperts #FreyrSolutions #LifeSciences
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Legacy conversions are essential for ensuring regulatory compliance and enhancing data accessibility in the life sciences sector. Managing document transformation, content remediation, and submission validation allows pharmaceutical organization to concentrate on product development without regulatory concerns requires expertise. to ensure precision. From conducting gap analyses to ensuring submission readiness, we keep your data compliant and future-proof. Want to know how we at Freyr Solutions, specialize in transforming legacy submissions into the latest eCTD formats, seamlessly adapting to evolving regulatory standards? Click here to know more - https://lnkd.in/dbeSTB7S #RegulatorySubmissions #eCTD #PharmaReg
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Reduce time, cost, and complexity by consolidating Regulatory submissions for the US, EU, and Japan. Grouped submissions ensure faster approvals, consistent data, and seamless global expansion. Ready to simplify your path to market? Let Freyr guide you through our carousel. #Freyrsolutions #RegulatorySubmissions #GroupedSubmissions
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Ensure compliance with local requirements and technical formatting, including specific modules and XML structure by understanding regulatory timelines and getting expert guidance. To know how with the right preparation, navigating NMPA's eCTD system effectively. Contact Freyr Solutions today to learn how we can support your successful market entry in China. https://lnkd.in/gjtPYEAB
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In developed markets, complex regulatory processes can delay product registration, impacting innovation and public health. Our latest whitepaper explores key challenges, including resource constraints and technological advancements, and proposes strategies like regulatory harmonization and tech-driven solutions to streamline the process. Read more to stay ahead! https://lnkd.in/da_aK2d3 #RegulatoryAffairs #ProductRegistration #Innovation
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FDA pre-submissions offer valuable feedback before you invest heavily in compiling regulatory dossiers for medicinal products. Align your strategy, clarify requirements, and address potential issues early on. Streamline your submission process, minimize risks, and boost approval chances. Engage with the FDA early to ensure your regulatory journey is on the right track! Want to know how to start your conversation? Contact us today. https://lnkd.in/gVazWrhs #RegulatoryAffairs #FDA #MedicinalProducts #PreSubmissions #HealthcareInnovation
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