Customer Requirement
A Global Generics pharmaceutical company with a diverse product portfolio sought to expand its market access to Malaysia and Chile. However, without a local legal entity in either country, the client needed a local Marketing Authorization (MA) holder to represent its products, manage regulatory obligations, and ensure continuous compliance with health authority requirements.
For generics, where speed-to-market and cost efficiency are critical, any delays due to dossier inadmissibility or regulatory gaps could directly impact competitiveness and revenue. The company required a trusted partner to ensure smooth entry and sustained compliance in both markets.
Problem Statement
The client faced several challenges typical for generic registrations in emerging markets:
- Mandatory local presence to act as MA holder and legally represent the company before agencies
- End-to-end compliance needs including regulatory communications and authority interactions
- Stringent data requirements for submissions on agency portals in Malaysia & Chile
- High risk of screening rejections/inadmissibility, particularly for generic dossiers with complex referencing requirements
- Ongoing lifecycle obligations such as renewals, variations, safety updates, and responses to authority queries
Without reliable local representation, the client risked loss of time-to-market advantage and non-compliance penalties, impacting both commercial timelines and market reputation.
Key Objective
To establish locally compliant MA holding in Malaysia and Chile, ensuring timely product approvals, minimizing dossier rejection risks, and providing robust lifecycle management for the client’s generic portfolio.
DDReg Solutions & Processes Adopted
DDReg, through its strong local alliances and regulatory expertise, implemented a structured MA holding solution:
- Local Representation: Acted as the official MA holder to fulfill legal requirements in both Malaysia & Chile
- Regulatory Submission & Compliance: Managed all regulatory communications, submissions, and authority interactions
- Dossier Due-Diligence: Performed rigorous reviews of the generic dossiers to avoid inadmissibility and screening rejections
- Data Quality Assurance: Ensured that high-quality data requirements were met on agency portals for faster acceptance
- Lifecycle Management: Supported renewals, variations, safety updates, and ongoing compliance activities post-approval
- Agency Coordination: Maintained proactive engagement with local health authorities to facilitate smooth approvals
Business Impact
By partnering with DDReg:
- The client achieved timely approvals in Malaysia and Chile without screening rejections.
- Regulatory compliance was maintained seamlessly, protecting market-entry timelines crucial for generics.
- Costly delays and resubmissions were avoided, strengthening the client’s competitive edge.
- Ongoing lifecycle support ensured sustained access and compliance of the client’s generics portfolio in both markets.
Key Learning
For global generics, local MA holding is a strategic enabler of market access. Success depends on proactive dossier due-diligence, strong local networks, and end-to-end compliance management. With a reliable partner like DDReg, generic companies can accelerate approvals, secure regulatory compliance, and maintain a competitive edge in emerging and mid-regulated markets.
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