Freyrsolutions

"Freyr provides US FDA Medical device registration services for device manufacturers that span across preparation & compilation of necessary documents for 510(k) submissions and successful FDA medical device establishment registration.
Freyr has been a trusted partner for the FDA medical device establishment registration services for medical devices and 510(k) submissions. We specialize in assisting medical device manufacturers with the registration process and ensuring compliance with US FDA regulations and requirements."

"Freyr provides FDA De-Novo Submission Services for medical device manufacturers that span across understanding De-Novo classification request and guiding throughout the classification process to obtain FDA clearance for novel devices.
Freyr has been a trusted partner for the FDA De-Novo submission services. Our team of experienced consultants specializes in understanding your FDA De-Novo classification request and guiding you through the De-Novo classification process in order to obtain FDA clearance for novel medical devices."

"Freyr provides US FDA 510(k) submission services for medical device manufacturers that span across preparation & compilation of necessary documents as per FDA 510(k) submission requirements/regulations.
We understand the importance of a successful US FDA FDA 510(k) submission for bringing your medical device to the market. Our expert team specializes in providing comprehensive support throughout the entire US FDA 510(k) submission process. With our knowledge and expertise, we ensure that your submission meets all the necessary 510(k) submission requirements for FDA 510(k) clearance. Our tea

"Freyr assists medical device manufacturers in FDA 510(k) clearance process that includes different types of 510(k) application submissions and preparation of necessary documents to meet USFDA regulatory requirements.
We specialize in providing comprehensive 510(k) services to assist you in navigating the FDA 510(k) clearance process for your medical devices. Our team of Regulatory experts is well-versed in the intricacies of FDA regulations, ensuring a smooth and successful journey toward obtaining the FDA 510(k) clearance. Explore our wide range of services tailored to assist you with you

"Freyr provides USFDA 510(k) Consultant support for medical device manufacturers that span across 510(k) document preparation & customized solutions throughout 510(k) clearance process for compliant 510(k) submissions as per FDA regulations.
For over a decade, Freyr has been a trusted partner for the US FDA 510(k) consulting services. Our team of experienced consultants specializes in providing comprehensive guidance and support throughout the FDA 510(k) clearance process. With their deep understanding of the FDA regulations and requirements, our expert FDA 510(k) consultants ensure that you

"Freyr provides FDA Q-Submission consulting services for medical device manufacturers that span across pre-submission meeting, Post Q-Sub activities, and compilation of device documents as per USFDA regulations.
US FDA has various mechanisms to facilitate interaction with the Agency regarding various applications that can be submitted for medical devices of varied risk classes. The early engagement with the Agency is facilitated through the request for feedback or a meeting with the US FDA under the “FDA Q-Submission Consulting Program”. This program enables interaction with the FDA on study

Freyr provides USFDA Medical device premarket approval process support for class III medical device manufacturers that span across preparation & review of the PMA application for successful PMA submissions as per US FDA regulations. The USFDA Premarket Approval (PMA) process is one of the device registration pathways provided by the US FDA, primarily designed for FDA Class III medical devices. The FDA PMA approval process for Class III devices entails meticulous scientific and regulatory evaluations to assess the medical device's safety and efficacy, ensuring the highest standards are met pri

The US FDA's medical device classification system in the United States of America predominantly depends on a predicate system for classifying medical devices. That is, drawing comparisons to legally marketed devices and determining the classification of I, II, or III based on the risk. To enable manufacturers, to determine the classification of their devices or to search for Substantially Equivalent (SE) of their devices, FDA provides a Medical Device classification database. In cases where the SE is not found, manufacturers can explore alternative options by submitting an FDA 513(g) Submissi

The Regulatory world is constantly changing, and to keep pace with the same compliantly, opting for medical device Regulatory consulting stands as a key for device and IVD companies. For over a decade, Freyr has been instrumental in keeping its customers aware of the updated regulations by providing compliant end-to-end Medical Device Regulatory Services. As a medical device Regulatory consulting services organization, Freyr ensures to bring safe, high-quality, and compliant medical devices and IVDs into the global markets faster. Our team of Regulatory experts will navigate the Regulatory co

Freyr Artwork 360 is an Artwork PLM Tool and a one-stop solution to all your Artwork lifecycle management needs

Freyr iREADY is a technology based cosmetics ingredients database platform that enables manufacturers in management of cosmetics ingredients and product formulae in global markets.

Freyr SPM is provides a complete solution for the Health Canada SPM requirements and supports in XML product monograph submissions like NDS, ANDSs, SANDSs, SNDS and all subsequent SPM submissions

Freyr Label 360 is a Drug labeling software for pharmaceutical Industry and it is a one stop solution for all regulatory labeling needs.

Freyr Submit PRO, an eCTD publishing software that allows the user to track, modify and review of eCTD documents until submissions to Health Authorities.

Freyr provides regulatory intelligence support for Lifesciences organizations for compliant market entry of products across the globe.

Freyr provides regulatory services and solutions in India to comply with CDSCO regulations for pharmaceuticals, medical devices, cosmetics, and food supplements manufacturing companies.

Freyr provides cosmetic regulatory services in Malaysia that span across cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation as per NPRA regulation

Freyr provides food regulatory services in Malaysia that span across food product registration, classification, formulation, ingredient assessment, technical dossier compilation and submission as per NPRA regulations

Freyr provides medical device regulatory services in Malaysia that span across medical device registration, medical device classification and market entry as per NPRA regulatory requirements

Freyr provides pharma/Medicinal product regulatory services in Malaysia as per NPRA regulations during Medicinal Product Registration, classification, Market authorization, Dossier Gap analysis and compliant with ACTD