Enabling regulatory approval success
Syngene’s regulatory services team formulates strategies that enable all stages (phase I – IV) of drug development to conform with various local and global regulatory requirements. Our team provides interdisciplinary strategic planning to arrive at the most effective and efficient pathway to achieve regulatory authorizations.
Our regulatory services team has a 100% success rate with obtaining regulatory approvals for clients. Our extensive experience, coupled with learnings from multiple engagements, has enabled us to effectively handle a wide variety of regulatory challenges on exigent timelines.
We provide a wide range of services, from comprehensive study management to any customized group of regulatory services, as per client requirements. We are proficient in various regulatory areas, including new chemical entities, new biological entities, generics or biosimilars in recombinant DNA (rDNA) products, monoclonal antibodies, and medical devices.
We also work on compiling regulatory dossiers in multiple formats, including formats such as common technical documents (CTD) and electronic CTDs (eCTD). Our experts work on strategies for preparing global regulatory submission documents in these formats to conform to the US food and drug administration (US FDA) standards and the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Our services include assistance with obtaining regulatory approvals for conducting phase I – IV clinical trials, including new indications and special population studies, and for bioavailability or bioequivalence studies. Our team also enables clients with obtaining no-objection-certificates (NOC) for the export of biological samples for testing, import licenses for drugs, performing safety reporting, and registering products for marketing approval.