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Sunset Clause, Generic Medicine, EMA, EU

freyrsolutions (#62) 1325 days ago News sunset clause generic medicine ema eu All https://genericspharma.freyrsolutions.com   Discuss  Published New Discard Success!

Freyr provides regulatory services for the queries related to the sunset clause and understanding the guidance related to sunset clause.

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Health Authority Interactions, Health Authority meetings EMA, EU

freyrsolutions (#62) 1325 days ago News health authority meetings ema eu All https://genericspharma.freyrsolutions.com   Discuss  Published New Discard Success!

Freyr helps Generic pharma manufacturers in EU & non-EU Health Authority interactions for pre-submission meetings and fast approvals of generics drug products

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Performance Evaluation Report (PER), EU IVDR, In Vitro Diagnostic Devices

freyrsolutions (#62) 1423 days ago News performance evaluation report (per) eu All https://medicaldevices.freyrsolutions.com   Discuss  Published New Discard Success!

Freyr helps In-Vitro Diagnostic Device (IVD) manufacturers in Performance Evaluation Report (PER) preparation, development of Performance Evaluation Plan, collecting & assessing the clinical evidence data, review and submission as per EU IVDR regulations for compliant market entry in Europe.