Biologicals- For Manufacturers
Biologicals- For Manufacturers
There are various regulatory approvals and NOCs required for manufacturing of biologicals in India and is a tedious process. It can be simplified and eased by expert regulatory backup and support. We provide end-to end regulatory support in obtaining the necessary license, approvals and NOC’s required for manufacturing of biologicals.
NOC for Form 29
Test licence is issued for the purpose of examination, test or analysis of biologicals. A NOC has to be obtained from the CDSCO for the purpose of carrying out test and analysis of Test batches for which Form 29 is submitted to the CDSCO.
At CliniExperts, we help you by guiding throughout the licensing/NOC process. For more information on our services contact.
Test License
Test licence is issued for the purpose of examination, test or analysis of drugs (biologicals). Form 29 is a licence to manufacture drugs (biologicals) for the purpose of Examination Testing and Analysis.
At CliniExperts, we help our clients by guiding throughout the licensing process. For more information on our services contact.
Post Approval Changes
The CDSCO needs to be intimated in case of any post approval changes for biological. The process can be eased by hiring a regulatory consultant. At CliniExperts, our team of experts will help you through the end-to-end process for any change that is made post approval for biologicals. For more information contact.
Marketing Authorization (Form 44, Form 46)
The manufacturer/sponsor have to submit application on Form 44 for permission of new drug (biologicals) approval under the provisions of Drug and Cosmetics Act 1940 and Rules 1945. Form 44 is an application for grant of permission to import or manufacture a new drug (biologicals). For manufacturers, it is obtained in Form 46. The requirements for Chemical and Pharmaceutical information are as per the International Submission requirements of Common Technical Document (CTD) and have five modules: Administrative/Legal Information, Summaries, Quality Information (Chemical, Biological and Pharmaceutical), Non-Clinical Information and Clinical Information.
CliniExperts, the leading global regulatory expert provides end to end regulatory solutions for Biologicals. For more information contact.
Permission for Clinical Trial (Phase 1, 2, 3) and Global Clinical Trial (GCT)
Biologicals are large, complex substances produced using recombinant DNA technology. 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. Permission is required from CDSCO for conducting any clinical trials in India.
We at CliniExperts are committed to get you necessary permissions for clinical trials and GCT by the CDSCO. For more information contact.