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Extending the Use of Antivirals to Treat Influenza in Infants

Certara scientists helped Roche apply an integrated clinical pharmacology program to support the development and global approval of Tamiflu for infants.

Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, PBPK Modeling & Simulation, PK/PD Modeling & Simulation
Therapeutic Area: Infectious Disease, Pediatrics
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6500 Narratives in 6 Weeks

A top-20 biopharma company used Certara’s regulatory writing services to write 6500 narratives in 6 weeks, based on a post-approval request from health authorities.

Solution: Regulatory & Medical Writing
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