Freyr helps medical device manufacturers with language translation, editing of medical device technical information in IFU, DSURs, SUSARs, Package inserts & labels for submission & approval process as per targeted regional languages with compliance to ISO 17100:2015 & ISO 9001:2008 standards.
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Freyr provides regulatory services and solutions in Sri Lanka to comply with NMRA to pharma, medical device, cosmetics and food supplement manufacturer companies.
Freyr provides pharma/Medicinal product regulatory services in Sri Lanka as per NMRA during Medicinal Product Registration, Market authorization and Dossier Gap analysis.
Freyr provides medical device regulatory services in Sri Lanka during medical device registration, classification and licensing as per NMRA regulatory requirements.
Freyr provides food regulatory services in Sri Lanka as per NMRA and FCA during food product registration, classification, formulation, ingredient assessment and technical dossier compilation.
Freyr provides cosmetic regulatory services in Sri Lanka as per NMRA and CESC during cosmetic product registration, classification, Notification, formulation, claims review, CPSR and technical dossier compilation.
Contact Freyr for End-to-End regulatory services in Sri Lanka to comply with NMRA regulatory Requirements.
Freyr’s regulatory services in USA for Diagnostic Kits span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
Freyr’s regulatory services in India for Diagnostic Kits span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
Freyr provides global regulatory services for Diagnostic kits span across registration, notification and classification in adherence with the regional compliance standards and fast track approvals for Covid-19 emergencies.
Freyr’s regulatory services in USA for Ultrasound Machines span across registration, notification and classification as per US FDA regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
Freyr’s regulatory services in India for Ultrasound Machines span across registration, notification and classification as per CDSCO regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies.
Freyr’s global regulatory services for Covid19 related products span across registration, notification and classification as per various Health Authority regulations to meet market entry requirements and fast track approvals for Covid-19 emergencies
Freyr provides Regulatory solutions and services for Generic pharma manufacturers to comply with Health Authority amendments and requirements during generic medicine dossier submissions.
Freyr provides the end-to-end ANDA regulatory services for generic pharma manufacturers/sponsors/ANDA applicants for approval of ANDA submissions to comply with USFDA requirements.
Freyr provides Regulatory services for Generic pharma companies/ANDA holders for preparation, review, and submission of ANDA as per Refuse-To-Receive (RTR) standards and FDA requirements.
Freyr provides regulatory support in Due diligence services to Generic pharma companies during Due Diligence of ANDA, review & assessment of ANDA submission strategies and risk-mitigation
Freyr helps Generics pharma manufacturers/ANDA holders during USFDA Health Authority interactions in pre-development, pre-submission content and format of their potential ANDA applications.
Freyr provides regulatory services to Generics pharma manufacturers/ANDA holders during Pre-submission Facility Correspondence (PFC) activities like ANDA Pre-Submission of Facility Information of Generic Drugs, fast review of the ANDA as per the USFDA requirements
Freyr provides regulatory services to the Generics pharma manufacturers/ANDA holders span across compilation, submission, and review of ANDAs for Competitive Generic Therapy approvals.