Customer Requirement: A biopharmaceutical company aimed to submit 19 biosimilar applications across various emerging and Rest of the World (ROW) markets within a short timeframe. The company required a regulatory strategy that addressed potential gaps, identified the most efficient submission pathways, and aligned with diverse regulatory expectations to ensure successful and timely approvals.
Problem Statement
The primary challenge was navigating the distinct regulatory landscapes of 19 different markets, each with unique submission requirements, timelines, and expectations. The company faced:
- Stringent Timelines: Rapid submission deadlines required efficient dossier preparation and execution.
- Diverse Regulatory Pathways: Each market had its own approval mechanisms, necessitating a customized approach.
- Potential Regulatory Gaps: Addressing variations in clinical, non-clinical, and quality requirements was crucial to avoiding delays.
- Efficient Compilation & Publishing: Some markets mandated electronic Common Technical Document (eCTD) submissions, while others required non-eCTD or paper-based filings.
The key objective was to ensure seamless submissions across multiple regions while maintaining regulatory compliance and expediting approvals.
DDReg’s Solutions & Processes Adopted: To ensure successful and timely submissions, DDReg conducted a comprehensive regulatory gap assessment to identify discrepancies in clinical, non-clinical, and CMC (Chemistry, Manufacturing, and Controls) data while aligning strategies with each market’s requirements. The team leveraged fast-track submission pathways where available, enabling expedited approvals and minimizing delays. A harmonized dossier preparation approach was implemented, creating a modular dossier structure that allowed for efficient customization per market-specific regulations. To meet aggressive deadlines, a parallel submission strategy was executed, ensuring simultaneous filings across multiple regions. Additionally, DDReg engaged with local regulatory authorities to clarify expectations, address potential gaps proactively, and maintain compliance with evolving regulatory standards. Efficient compilation and publishing of submission dossiers were carried out using electronic Common Technical Document (eCTD) and non-eCTD formats, ensuring seamless compliance with each country’s regulatory framework.
Achievement & Business Impact: Through this strategic and structured approach, DDReg successfully facilitated the timely submission of 19 biosimilar applications within the stipulated deadlines, minimizing regulatory queries by addressing potential gaps proactively. The optimized regulatory strategy enabled faster market entry by leveraging fast-track approval pathways and ensuring seamless compliance with diverse regulatory landscapes. By navigating complex submission requirements efficiently, DDReg helped the pharmaceutical company expand biosimilar access across multiple emerging and ROW markets, reinforcing its position in the global market. The success of this initiative further strengthened DDReg’s reputation as a trusted regulatory partner for handling complex multi-market submissions.