Regulatory Services

Synapse 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