Overview
A regional pharmaceutical distributor with 60+ registered products in Malaysia needed a partner to manage the ongoing compliance burden of renewals, variations, and label updates freeing their internal team to focus on commercial operations.
The Challenge
60+ active product registrations across multiple principals, each with different renewal dates, variation requirements, and labelling standards. Missed renewal deadlines on two products had already created temporary market withdrawal incidents.
Our Approach
Full portfolio audit. Built a master compliance calendar tracking every renewal, variation, and required action
across all 60+ products. Established quarterly reporting cadence. Managed all NPRA correspondence directly the client received only outcomes and exceptions, not operational burden.
The Outcome
Zero missed renewal deadlines in the two years following engagement. 14 variations and label updates processed across the portfolio.