GenBiosis provides regulatory support to its clients by serving as a crucial link between sponsors and health authorities. We understand how vital scientific documentation is for the successful and compliant rollout of products.
Our regulatory service offerings include:
– CDSCO Applications and Approvals
– Regulatory support during the development stage (protocol writing for BA/BE studies, Phase I, Phase IIa/IIb, Phase III, and Phase IV, as well as BE NOC and import licenses)
– Clinical Study Report writing
– Pre-IND applications and scientific advice meetings
– Support for regulatory dossiers
– Dossier gap analysis
– Assistance with external agency regulatory audits and addressing regulatory observations
– Translations (SmPC, Patient Information Leaflets, and Labelling)
– Module e-CTD compilations
– Module writing
– Control correspondence