Freyr provides regulatory services for the queries related to the sunset clause and understanding the guidance related to sunset clause.
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Freyr provides Brexit regulatory services to Generic medicine manufacturers for those who are ready to market their products in United Kingdom (UK) and Europe (EU)
Freyr provides Regulatory strategic consulting and resources services like Market Authorisation Holder (MAH), local representative, Qualified Person (QP) and Qualified Person for Pharmacovigilance (QPPV) services
Freyr provides regulatory services to Generic medicine manufacturers in post-approval changes and submissions to European health authorities
Freyr provides regulatory affairs services in compilation, review, and submission of Active Substance Master Files (ASMF) and CEP submission in eCTD format as per EU health authorities guidelines
Freyr helps Generic pharma manufacturers in EU & non-EU Health Authority interactions for pre-submission meetings and fast approvals of generics drug products
Freyr provides Marketing Authorization Application (MAA) registration services to the generic medicinal product manufacturers for registration and distribution of generic medicinal products in the EU countries
Freyr provides regulatory services to generic pharma companies for handling Marketing Authorization Application (MAA) submission approval to the EU countries as per the EU regional Health Authorities requirements.
Freyr helps Generic pharma manufacturers/ANDA holders in ANDA pre-submission meetings with the USFDA for Product Development, Pre-submission and ANDA assessment
Freyr provides regulatory support in managing and updating the Drug Master File (DMF) as per USFDA guidelines and helps in DMF gap analysis, DMF submissions in eCTD format.
Freyr provides regulatory services to the Generics pharma manufacturers/ANDA holders in post-approval changes in ANDA and DMF submissions as per the USFDA requirements
Freyr provides regulatory services to Generic pharma manufacturers/ANDA holders in ANDA product development process, planning and submissions with successful commercialization of drug products
Freyr provides regulatory services to the Generics pharma manufacturers/ANDA holders span across compilation, submission, and review of ANDAs for Competitive Generic Therapy approvals.
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 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 support in Due diligence services to Generic pharma companies during Due Diligence of ANDA, review & assessment of ANDA submission strategies and risk-mitigation
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 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 solutions and services for Generic pharma manufacturers to comply with Health Authority amendments and requirements during generic medicine dossier submissions.
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.