Successful filing of initial IND and IND-LCM submissions. Decode how Freyr succeeded in filing the ad hoc submissions to the FDA and helped the client with their business requirements while maintaining high quality. Download the proven case. https://lnkd.in/gtvyWQPc #Pharmaceuticals #PublishingandSubmissions #INDLCMSubmission #ZeroErrors #FreyrSolutions #ProvenCase
Freyr Solutions’ Post
More Relevant Posts
-
Did you miss this headline? 📰 On December 15, the FDA announced the final approval and implementation of required labeling updates to address the evolving opioid crisis in the U.S. 🔍 Review and keep your products labeling up to date—our team of regulatory experts can help! Learn more ➡️ https://lnkd.in/gKjuJkvQ #FDA #pharmaceuticals #genericdrugs #regulatorycompliance
-
Beyond IDMP – Act Now to Reap the Benefits of eCTD 4.0 Compliance Read how here - https://lnkd.in/g--6dnPz #eCTD4 #RegulatoryCompliance #Pharmaceuticals #DataManagement #ComplianceStandards #PharmaceuticalOutsourcing
-
-
Join us for the next webinar in our series: An Introduction to Dry Powder Inhaler (DPI) Testing. Ideal for those who have questions about the regulatory landscape governing DPI testing or those seeking effective troubleshooting strategies for common testing challenges, the webinar offers something for everyone. 📅 Save the date: 27th March 2024 Register now to secure your spot! 📍 10:00 AM Eastern: bit.ly/3uG4btl #InhalerTesting #DPI #Pharmaceuticals #Pharma #Formulations #WebinarWednesday
-
-
Successful filing of LCM-grouped Submissions for an IND. Decode how Freyr could file valid submissions to the USFDA with zero errors and warnings. Download the proven case. https://lnkd.in/dVJNcnQ5 #Pharmaceuticals #PublishingandSubmissions #LCMGroupedSubmissions #CaseStudy #ZeroErrors #FreyrSolutions
-
Accelerated content build without breaking legal and regulatory process and manage the lifecycle is the goal.. Modular content is the keys to the car. The day has come to connect with HCPs with what they want and not junk.
See how you can fulfill HCPs thirst for info while maintaining compliance and ensuring that the right message is delivered on time: https://bit.ly/3PxyGYN. #pharmaceuticals #contentstrategy
-
Successful filing of original ANDA & Response to Query submissions to the USFDA. Decode how Freyr worked against time to file the submissions with zero errors and warnings while maintaining the lifecycles for multiple products. Download the proven case. https://lnkd.in/dmAirBbg #Pharmaceuticals #PublishingandSubmissions #OriginalANDASubmission #ResponsetoQuery #ZeroErrors #LCMMaintenance #TwostepReview #USFDA #CaseStudy #ProvenCase
Successful Filing of Original ANDA & Response to Query Submissions
freyrsolutions.com
-
📚💊 Proud to have participated in the insightful webinar on "FDA Drug Topics: Important Orange Book Facts"! FDA #FDAWebinar #OrangeBook #Pharmaceuticals #RegulatoryAffairs #DrugDevelopment #HealthcareCompliance #ProfessionalDevelopment
-
-
Independent Senior Consultant in Health Policy, HTA and HEOR and Personal Chair Professor
The Implementing Regulation on Joint Clinical Assessment #HTAR #JCA published by the European Commission on May 23, 2024 contains two important changes when compared with the draft act that was in public consultation in March. #HTA #Europe #MarketAccess #pharmaceuticals
-
Our March Case Study is now ready for you to download as a PDF. A 7-minute read worthwhile to understand how we support our customer to navigate the transition of a greenfield site. #pharmaceutical #itot #digitaltransformation #compliance #biopharma #itoperations #managedservices
Our first case study from Q1 2024 is now available as a PDF. Feel free to download and understand: What is involved when moving from a greenfield site to full-scale operations. How to address both IT and OT during the delivery of support. The impact of regulations and FDA guidance on the priorities. Find the associated blog and much more here: https://lnkd.in/eBD6smsG Happy Reading! #pharmaceuticals #biopharma #pharmalab #ITOT #ITOTgap #ITOTconvergence #digitaltransformation #CDS #itoperations
-
SAVE THE DATE! Join us on June 28th at 1 PM EST for an eye-opening virtual event that aims to decode the FDA's warning letter process! 📆🔎 Discover the intricacies of this crucial aspect of the pharmaceutical industry and gain insights from industry experts. Don't miss this opportunity to expand your knowledge and stay ahead of the game! 💼💡 Click the link below to secure your spot and mark your calendars. We can't wait to see you there! 👉 https://lnkd.in/eABqGdFf #VirtualEvent #FDAInsights #PharmaIndustry #KnowledgeIsPower #warningletterfromFDA #FDA #warningletter #keynotespeaking #keynotespeaker #businessowners #smallbusiness #pharmaceuticals #consulting
-
