Regulatory Guidelines
At DRF, studies are conducted under good laboratory practice (GLP) regulations in compliance with the following regulatory guidelines:
OECD:
Organization for Economic Co-operation and Development
Schedule Y:
Drugs and Cosmetic Act 1947, Government of India
EPA(OCSPP):
Environmental Protection Agency
EU:
European Union
ICH:
International Conference on Harmonization
CIPAC:
Collaborative International Pesticides Analytical Council Limited
CPCSEA:
Committee for the Purpose of Control And Supervision of Experiments on Animals.
Organization for Economic Co-operation and Development
Drugs and Cosmetic Act 1947, Government of India
Environmental Protection Agency
European Union
International Conference on Harmonization
Collaborative International Pesticides Analytical Council Limited
Committee for the Purpose of Control And Supervision of Experiments on Animals.
We can carry out studies as per other sponsor defined guidelines. The regulatory requirements, model selection and the established procedures are critically evaluated during study plan preparation.