The import of biologicals needs special attention as well so as to ensure its safety, efficacy and availability. As per requirements of cdsco the importer of biologicals/vaccines etc has to ensure that the drugs which are proposed to be imported into India for marketing- is of Standard Quality, always. As per definition of cdsco- a biological drug is never an old drug, therefore each importer has to file for the corresponding new drugs application along with parallel import registration application. For new research-based products, Clinical Trials would also be needed to be conducted, before the same is approved by the office of cdsco.

Our team at Raj Pharma Consultancy caters to all intricate details of each application – step by step to ensure positive outcome at the end of the project timelines.

Each application is given full attention which it requires during the processing of the same form the stage of preparation for filing till the final approval being issued.