Freyr provides regulatory services to the Generics pharma manufacturers/ANDA holders span across compilation, submission, and review of ANDAs for Competitive Generic Therapy approvals.
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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 in post-approval changes in ANDA and DMF submissions as per the USFDA requirements
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 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 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 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 helps Generic pharma manufacturers in EU & non-EU Health Authority interactions for pre-submission meetings and fast approvals of generics drug products
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 provides regulatory services to Generic medicine manufacturers in post-approval changes and submissions to European health authorities
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 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 services for the queries related to the sunset clause and understanding the guidance related to sunset clause.
Freyr provides regulatory services in Canada to Generic medicine manufacturers/ANDS holders in regulatory submission strategies for submission timelines, documents required for submission, approval process and registering generic medicine as per Health Canada requirements
Freyr provides regulatory support in managing and updating the Drug Master File (DMF) as per Health Canada guidelines and helps in Master file submissions in eCTD format.
Freyr provides regulatory support in ANDS change control evaluation/assessment, post-approval submission strategy and preparation of change-related submission packages as per Health Canada requirements
Freyr helps Generic pharma manufacturers/ANDS holders in Health Canada (HC) interactions which include discussing and clarification of potential risks and issues related to their ANDS applications for fast approvals of generics drug products.
Freyr provides regulatory service in Canada to Generic medicine manufacturers/ANDS holders for preparation, review, and submission of Abbreviated New Drug Submissions (ANDS) as per Health Canada requirements.
Freyr provides regulatory and product registration support in Nigeria to comply with NAFDAC to pharma, medical device, cosmetics, and food supplement manufacturer companies.
Freyr provides pharma/Drug product regulatory support in Nigeria to comply with LFN, NAFDAC during Drug Product Registration, Market authorization, Dossier Gap analysis and Product Approval Meetings.