Customer Requirement
A leading pharmaceutical company wanted to expand access for its intrauterine devices (IUDs) across emerging markets, including GHC, ASEAN, LATAM, and South Asia. To do so, the client needed a locally compliant Marketing Authorization (MA) holder to represent its products, manage regulatory obligations, and ensure timely approvals.
For IUDs, where regulatory scrutiny is high and timelines are tight, any delays in submission or compliance gaps could disrupt market entry and affect product availability. The client required a trusted partner to navigate local regulations and accelerate approvals while maintaining compliance across multiple countries.
Problem Statement
The client faced several challenges typical for emerging-market submissions of medical devices:
- Establishing a local MA holding facility to meet legal and regulatory requirements.
- Short timelines for dossier submission and approval, leaving little room for delays.
- Coordination with multiple stakeholders, including CMOs and local partners, to compile accurate data.
- Ensuring all regulatory and business validation requirements were addressed to avoid delays or rejection.
Without a compliant local presence and strong submission strategy, the client risked delayed approvals, non-compliance penalties, and disruption to market access.
Key Objective
To establish a locally compliant MA holding facility and ensure timely regulatory submissions for IUDs, while coordinating effectively with CMOs and local partners to reduce risks of delays and ensure smooth market entry.
DDReg Solutions & Processes Adopted
DDReg implemented a structured, end-to-end solution to address the client’s needs:
- Local MA Representation: Established compliant local MA holding to meet legal requirements across multiple emerging markets.
- Regulatory Planning & Coordination: Developed a detailed plan aligning submissions with country-specific regulatory expectations.
- Stakeholder Collaboration: Worked closely with CMOs and local partners to gather accurate data and ensure completeness of submissions.
- Proactive Monitoring: Maintained oversight to anticipate regulatory challenges and address potential gaps before they could impact timelines.
Business Impact
By partnering with DDReg:
- The client successfully established MA holding in targeted emerging markets.
- Timely submissions were achieved, reducing the risk of approval delays.
- Compliance across multiple markets was maintained seamlessly.
- Confidence in cross-border coordination and regulatory readiness was strengthened.
Key Learning
Early identification of critical business validation requirements is essential for smooth submissions, and close collaboration with CMOs and local partners helps mitigate risks when timelines are tight. Combined with a proactive, strategic regulatory approach, these elements ensure efficient market entry and sustained compliance across emerging markets.
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