Freyrsolutions

Freyr provides Regulatory Software, Automation and Digital Transformation Solutions to support Global Lifesciences companies.

Freyr provides end to end regulatory support that span across the Covid-19 development lifecycle, marketing authorization, submission of Vaccine BLA, registration, lifecycle management ofvaccine and their regulatory needs.

Freyr supports life science companies during Patient Support Applications, Pharmaceutical Press Releases, pharma advertising and avoid the issues of Prescription Drug Promotion (OPDP)

Freyr is a Strategic Regulatory partner providing end-to-end Regulatory solutions and services to Innovator pharma companies during their innovator drug development process.

Contact Freyr for Nigeria End-to-End regulatory services to comply with NAFDAC regulatory Requirements for Drugs, Medical Devices, Cosmetics, Food Supplement Product registrations.

Freyr provides cosmetic regulatory services in Nigeria as per NAFDAC during cosmetic product registration, classification, Notification, formulation, clams review, CPSR and technical dossier compilation.

Freyr provides food supplements regulatory services in Nigeria as per NAFDAC during food product registration, classification, formulation, ingredient assessment and technical dossier compilation.

Freyr provides medical device regulatory services in Nigeria during medical device registration, classification, and licensing as per NAFDAC regulatory requirements.

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.

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 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 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 support in ANDS change control evaluation/assessment, post-approval submission strategy and preparation of change-related submission packages 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 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 services for the queries related to the sunset clause and understanding the guidance related to sunset clause.

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