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: Environmental Protection Agency

EU: European Union

ICH:
International Conference on Harmonization

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.