IP Management and Global Regulatory Support
Abiozen understands that intellectual property protection and regulatory alignment are critical enablers of long-term success in the pharmaceutical sector. Our integrated IP and regulatory affairs teams offer comprehensive, end-to-end support to ensure that client innovations are protected and regulatory milestones are achieved across multiple global jurisdictions.
Patent Filings and Protection
We provide strategic oversight for the development and filing of patents related to proprietary processes and formulations. Drawing from best practices used by Curia Global, our IP management services safeguard client innovations against infringement and position them for long-term market exclusivity. This includes both initial filings and ongoing portfolio maintenance across major patent offices.
Global Regulatory Submissions
Our regulatory specialists manage submissions to international agencies, including the USFDA, EMA, TGA, and PMDA. From dossier preparation to strategic compliance consulting, we streamline regulatory pathways to minimize review times and ensure first-cycle approvals. Our approach mirrors Thermo Fisher CRDMO’s global regulatory model, providing clients with efficient and scalable regulatory execution.
DMF Preparation and Maintenance
We develop and maintain high-quality Drug Master Files (DMFs) to support client product registrations and partner filings. These DMFs are fully aligned with ICH and regional standards, containing robust technical, quality, and safety data. Following a model refined by Thermo Fisher Patheon, our DMF services are structured for transparency, traceability, and long-term lifecycle support.
Accelerated Market Access
By combining strategic IP protection with expert regulatory navigation, Abiozen reduces approval timelines and mitigates compliance risks. Our teams work in close collaboration with clients, offering regional insights and regulatory intelligence to ensure seamless global entry, long-term protection, and successful commercialization of super generic APIs.
Connect with Abiozen
We thrive on tackling complex challenges—and we’d love to learn about yours. Reach out to explore how we can support your program’s unique requirements.
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IP Management and Global Regulatory Support: Comprehensive intellectual property and compliance solutions for seamless market entry
property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste
Advanced Crystallization and Purification Techniques: Cutting-edge processes for superior purity and stability.
processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards.
High-Volume API Synthesis: Precision-driven, scalable production to meet global demand
global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards. real-time environmental monitoring to guarantee sterility.
IP Management and Global Regulatory Support: Comprehensive intellectual property and compliance solutions for seamless market entry
property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste
Advanced Crystallization and Purification Techniques: Cutting-edge processes for superior purity and stability.
processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste management systems to uphold safety and environmental standards.
IP Management and Global Regulatory Support: Comprehensive intellectual property and compliance solutions for seamless market entry
property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste