With decades of international experience, we expertly guide you through complex global landscapes, so you can innovate with greater focus and confidence.
With our international experience in the highly specialized world of controlled substances and a proven track record of successful global submissions, Benuvia’s regulatory affairs team makes navigating approvals and market access seamless. QA plays a critical role in ensuring every submission, from DMFs, INDs and CTAs to NDAs, BLAs, and beyond, meet the highest standards of accuracy, compliance, and data integrity. From managing amendments, supplements, and product reviews to providing audit-ready documentation, our end-to-end regulatory services are reinforced by rigorous QA oversight, keeping you in control and confident every step of the way.
Navigating the complex world of regulatory approvals has always been daunting until we partnered with Benuvia. Their RAC-certified leadership and experienced team guided us through every step, from IND to NDA, ensuring our submissions were accurate, timely, and fully compliant. Their expertise gave us the confidence to focus on innovation while they managed the regulatory landscape.
Oncology-Focused Pharma Client
Vice President of Regulatory Affairs
We offer a full spectrum of flagship regulatory affairs services designed to meet the evolving needs of our clients. These services ensure compliance, reduce time-to-market, and support your strategic goals.
Benuvia offers unparalleled expertise in navigating the ever-changing, global regulatory landscape. With an RAC-certified leader and a team that has managed over 500 successful submissions, we ensure your applications are thorough, accurate, and fully compliant with all applicable standards. By reducing the risks of delays, rejections, or costly rework, we give you the confidence to focus on your innovation while we handle the complexities of regulatory approval.
Benuvia simplifies the path to international approvals with a deep understanding of regulatory requirements across global markets. Whether you’re seeking FDA clearance, EMA approvals, or regional certifications, our team provides seamless guidance through every step. With expertise in multi-market submissions, we ensure your product can successfully enter and compete on the global stage, unlocking new opportunities for growth and success.
Time is critical in the regulatory landscape, and Benuvia’s efficient processes are designed to keep your project moving forward. From early-stage planning to submission and follow-up, we identify potential challenges in advance, proactively resolving them to avoid unnecessary delays. With our commitment to accuracy and compliance, we help you achieve your milestones faster while maintaining the highest standards of quality.
No two regulatory journeys are alike, and Benuvia excels at crafting customized solutions to address unique challenges. Whether managing complex INDs, CTAs, NDAs, or BLAs—or handling amendments, supplements, and variations—we adapt our approach to meet your product’s specific needs. By tailoring pathways that align with your objectives, we streamline the regulatory process and help you stay on track for success.
Benuvia’s regulatory processes are supported by QA to ensure all documentation, submissions, and compliance efforts meet exacting standards. QA reviews audit trails, validates data, and aligns with global regulatory requirements, streamlining approvals and giving clients confidence in their market strategies.
At Benuvia, we collaborate with you is key to fully understand your goals and challenges, creating tailored strategies that align with your specific needs and deliver exceptional results. Through clear, transparent communication and a proactive approach, we eliminate inefficiencies and roadblocks, ensuring that every submission is completed smoothly and on time.
Your intellectual property is the cornerstone of your success, and Benuvia takes every measure to protect it. From secure data management systems to strict confidentiality protocols, we safeguard your proprietary information at every stage of the regulatory process. With our expertise and dedication, you can trust that your IP is in safe hands, allowing you to maintain your competitive advantage without compromise.
Explore our regulatory case study to learn how we’ve guided clients through complex compliance challenges with precision, insight, and strategic expertise to deliver robust compliance, minimize delays, and achieve regulatory excellence across global markets.
Esther Hendrickson, Head of Regulatory Affairs, has 20-plus years of expertise in regulatory strategy and project management across therapeutic areas such as oncology, dermatology, hematology, and rare diseases. Her experience spans the full product lifecycle, from pre-IND to post-marketing submissions, ensuring compliance with global regulatory authorities, including the FDA, EMA, and Health Canada.
Esther brings extensive knowledge of GMP, GCP, and GLP compliance, as well as expertise in managing INDs, IDEs, and other critical filings. She holds a bachelor’s degree in biology from SUNY Plattsburgh and a master’s degree in information systems management from Keller Graduate School of Management.
Esther is passionate about helping clients navigate complex regulatory landscapes and is eager to share her insights, answer questions, and provide solutions to advance your projects.
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