Clinical Pharmacology Strategy

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Maria Saluta

Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Regulatory Submissions Management

Strategic Regulatory and Medical Writing

Strategic Writing Leadership is Key to Successful Drug Development There is tremendous complexity and variability in any drug development program. It takes leadership and strategy to develop one story and a plan that considers all variables and contingencies. Sponsors need a trusted, agile, and experienced partner not only to prepare these documents, but also to […]

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