Perhaps the most important leg of clinical research are biological products and their procurement. Often research and product launches are delayed due to red tape and paperwork over government guidelines at this very initial step. CliniExperts specializes in cutting through this chaos and setting your clinical research on a smooth sailing journey right from this step. We understand the importance of timelines and function as a well-oiled machinery that can deliver services on the expected date and time, glitch- free.
By applying technology, creativity and focused multi-disciplinary approach, internally as well as externally, we improvise processes and accelerate approvals. Our service aims at leveraging models that are cost effective in the long run and help in growth of new products along with sustenance of established products. We commit to periodic and smooth safety reporting to regulatory authorities and global Ethics Committees.
The Indian Council of Medical Research (ICMR) has set stringent guidelines and certificates to be obtained for various types of biological material samples. It regulates by way of periodical revisions in addition to approvals from CDSCO. Approvals are also required by other offices and agencies at the district, zonal state and national level.
New licences must be obtained by the importing party for products utilizing rDNA technology, even though the product is physically/chemically similar to existing naturally occurring products or existing products in the conventional system. The products must clear all safety guidelines for the packaging of the samples, and manner of import. CliniExperts can help you ensure thorough compliance at every step of your import.
To initiate a study requiring biological samples is not easy. Many obstacles plague the approval process from authorities. Yet, it is not impossible if you are well prepared with all the necessary documents and answers that the regulatory authorities demand to clear your NOC applications. With CliniExperts on your side, you will never have to worry about a missed deadline. Our senior regulatory experts are dedicated to maneuvering swiftly through ethics approvals and complex regulatory processes so that studies and product launches start off on the right foot, timely.
Our strong networks with health authorities and regulatory committees gives CliniExperts a bird’s eye view of the entire process without missing out strategic details.
CliniExperts provides end to end registration and licensing assistance for biological samples as well as vaccines and sera.