A new drug has to undergo hard core clinical trials on human beings before it is launched for marketing. The studies on humans have always been a matter of high concern when it comes to ethical issues. To overcome and keep check on such controversies, the government has set certain standards which have to be fulfilled before proceeding towards the conduct of clinical trials.
The regulatory department ensures that the clinical trials conducted must be in compliance with the regulatory standards and guidelines (like GCP-ICH, GMP, GLP, FDA etc). The regulatory Affairs department is a link between the company/ sponsor and the government. It scrutinizes every aspect related to regulations of clinical trial during drug approval. Drug approval by the regulatory authorities is necessary prior to market launch of the product.
CRO-India helps in consultancy regarding regulatory affairs. Having rapport with the authorities, CRO-India has in-depth knowledge of all concerned regulatory affairs related to steps for drug approval. The services provided by CRO-India for Regulatory Affairs include:
Clinical Research Regulatory Affairs
Pharmaceutical Regulatory Affairs
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