Biologicals are large, complex substances produced using recombinant DNA technology. These include vaccines, blood products, stem cells or other DNA products. The Central Drugs Standard Control Organization (CDSCO) plays a vital role in regulating the manufacture and import of these biologicals in India. It not only ensures their safety, efficacy and quality, but also enforces the regulations on the companies that manufacture it.
Biologicals are the vital products for various health conditions such as arthritis, HIV, hepatitis and many more. However, the manufacture and approval of biologicals is often rejected due to incomplete paperwork due to the stringent regulations. Our role here at CliniExperts is to ensure that our clients are aware of these guidelines and accomplish them accurately so that their product is approved to go out in the market. Our well-trained staff applies both creativity and technology to create and expedite approvals.
The application for the GCT is a series of 31 categories that needs to be provided regarding the clinical trial being performed. Concisely, the categories include: