Freyr Solutions’ Post

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 #OriginalANDASubmission #ResponsetoQuery #ZeroErrors #LCMMaintenance #USFDA

Successful filing of LCM-grouped Submissions for an IND. Decode how Freyr was able to 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

Successful filing of LCM-grouped Submissions for an IND. Decode how Freyr was able to file valid submissions to the USFDA with zero errors and warnings. Download the proven case. https://lnkd.in/dVJNcnQ5   #Pharmaceuticals #RegulatorySubmissions #LCMGroupedSubmissions #CaseStudy #ZeroErrors 

With the effort to improve patient safety and compliance pharmaceutical manufacturers and regulatory authorities have increased their scrutiny of the supply chain’s ability to delivery even greater levels of quality. This expectation brings even more challenges to bringing product to the market involved complex and costly drug development and requirements for greater efficiency in manufacturing. To meet these requirements, choosing the appropriate quality of containment systems from the outset is critical to the successful industrialization of an injectable drug product. Learn more in this article: https://bit.ly/4b5WfRd

With the effort to improve patient safety and compliance pharmaceutical manufacturers and regulatory authorities have increased their scrutiny of the supply chain’s ability to delivery even greater levels of quality. This expectation brings even more challenges to bringing product to the market involved complex and costly drug development and requirements for greater efficiency in manufacturing. To meet these requirements, choosing the appropriate quality of containment systems from the outset is critical to the successful industrialization of an injectable drug product. Learn more in this article: https://bit.ly/4b5WfRd

With the effort to improve patient safety and compliance pharmaceutical manufacturers and regulatory authorities have increased their scrutiny of the supply chain’s ability to delivery even greater levels of quality. This expectation brings even more challenges to bringing product to the market involved complex and costly drug development and requirements for greater efficiency in manufacturing. To meet these requirements, choosing the appropriate quality of containment systems from the outset is critical to the successful industrialization of an injectable drug product. Learn more in this article: https://bit.ly/4b5WfRd

Regulatory support in labeling and artwork for an ANDA. Decode how Freyr supported an India-based pharma company in the creation and review of ANDA labeling documents and artwork annotations per the USFDA Regulatory requirements. Download the proven case. https://lnkd.in/eEp-iYZn  #ANDA #USFDA #RegulatorySubmissions #Pharmaceuticals #RegulatoryAffairs  

With the effort to improve patient safety and compliance pharmaceutical manufacturers and regulatory authorities have increased their scrutiny of the supply chain’s ability to delivery even greater levels of quality. This expectation brings even more challenges to bringing product to the market involved complex and costly drug development and requirements for greater efficiency in manufacturing. To meet these requirements, choosing the appropriate quality of containment systems from the outset is critical to the successful industrialization of an injectable drug product. Learn more in this article: https://bit.ly/4b5WfRd

Exciting developments in the FDA's draft guidance on Prescription Drug Use-Related Software (PDURS) have sparked important conversations within the pharmaceutical industry. Our team has been closely following this framework and engaging with stakeholders to stay ahead of the curve. What are your thoughts on the impact of these regulatory considerations? https://ow.ly/vucl50RFUWs #FDA #pharmaceuticals #PDURS #regulatoryaffairs Marty Culjat, Kory Dillman, Scott Kellogg