Sakthimaan Singh
Experienced Regulatory Affairs Executive specializing in Injectables and Ophthalmics for the US market. Proven expertise in FDA submissions, Analytical method validation.
- Role
- Regulatory Affairs Executive at Caplin Point Laboratories Ltd
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Sakthimaan Singh
working experiences
Experience
Regulatory Affairs Executive
Sep 2023 — Present · Chennai, IN
Review and submission of Dossier for US market(Injectable & Ophthalmics)(Pharmaready), CMC Activity,Review of Technical Documents(Specification, Stability, Risk Assessments, Analytical Method Validation activity.Change Control Activity (Ample logic) and DMS (Labware).
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