Overview
A South Korean skincare brand with strong retail presence in Singapore engaged us to manage their ongoing post-market regulatory obligations including Adverse Event Reporting, label variation submissions, and annual product safety updates.
The Challenge
2 adverse event reports filed within a single year, 11 label variations triggered by ingredient and packaging
updates, and a scheduled HSA product safety assessment all managed across a growing portfolio by a commercially focused Singapore team with no in-house regulatory expertise.
Our Approach
We became their embedded Singapore regulatory team handling all HSA correspondence, adverse event documentation, and variation submissions. Established a structured new-product intake process so any change to existing products automatically triggered a compliance review before reaching market.
The Outcome
All 2 adverse event reports filed within HSA timelines with no regulatory action taken. 11 label variations processed. HSA safety assessment passed without issue. Client has maintained clean compliance status for 18 consecutive months.