This section brings together the existing Pharegis technical materials on clinical and preclinical studies used to support medicinal product registration. The library covers clinical-study requirements, Phase I–III development and preclinical work for pharmaceuticals and biopharmaceuticals, including in-vitro studies.
The individual guides retain their original publication dates, historical hit counts and established search URLs.
Technical library
Development programmes supporting medicinal product registration
Clinical study planning and execution for medicinal product registration in Russia, including regulatory requirements, submissions and study support.
Regulatory and operational support for Phase I and Phase II clinical studies in Russia, from study planning and submissions to local execution.
Regulatory and operational support for Phase I and Phase II clinical studies in Russia, from study planning and submissions to local execution.
Preclinical study requirements and support for pharmaceutical registration in Russia, including program planning, documentation and regulatory strategy.
Preclinical study support for biopharmaceutical registration in Russia, including study strategy, documentation and regulatory requirements.
In vitro preclinical study support in Russia for pharmaceutical development and registration, including regulatory planning and documentation.
