Regulatory ServicesSynapse proactive regulatory support for its clients helped us to understand how significance of the role by Synapse – acting as a guiding link between the sponsor and HA. We understand how critical is the scientific documentation for successful product rollout in a compliant manner. Our regulatory service offerings are as follows; span around;
- Regulatory support at developmental stage (protocol writing for BA/BE studies, phase 1 Phase IIa/IIb , Phase III and Phase IV, BE NOC and Import licenses)
- CSR writing for developed markets
- Pre IND application/scientific advice meetings.
- Support development of submission ready regulatory dossiers for most HA’s to seek MAH approvals.
- Dossier Gap Analysis for various regulatory market, PIL User Testing,
- DMF Preparation and Filing.
- Support and train on external agency regulatory audits and addressing 483 observations.
- Regulatory Labelling Services
- eCTD publishing