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.
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.
"*" indicates required fields
Notifications
