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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.
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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.
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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
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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)
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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
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Freyr provides regulatory services to Generic medicine manufacturers in post-approval changes and submissions to European health authorities
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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.