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Members of the ELIQUENT team - Christine Scheve, MSBME, Heidi H., Mikio Ishizawa, and Igor Ilievski MD MBA - will be in San Diego the week of June 3rd for the annual Biotechnology Innovation Organization International Convention. Schedule a meeting with the team via [email protected]
Please join us in congratulating Donald Ashley and Kalah Auchincloss on stepping into new leadership roles within ELIQUENT Life Sciences' Quality & Compliance Practice. With their rich experience and deep regulatory expertise, they bring immense value to our team, further enhancing our ability to provide top-tier guidance in the life sciences industry.
ELIQUENT Life Sciences is pleased to announce expanded leadership roles for two former FDA senior officials - Donald Ashley and Kalah Auchincloss. As Principals of Regulatory Compliance, Don and Kalah bring a wealth of experience and deep regulatory knowledge to clients navigating today’s evolving regulatory environment. Learn more about our team of unmatched experts at https://lnkd.in/ev2b7Uuq
This white paper is a must-read for effective and efficient FDA meeting management. ELIQUENT examines the evolving PDUFA meeting types and formats, while providing best practices, valuable insights, and practical tips to optimize FDA meetings and interactions.
Efficient and effective FDA meetings are crucial for any innovator bringing new products to market. In a new ELIQUENT Life Sciences white paper, Tanvi Mehta and Guangyuan Li examine best practices for optimal FDA meetings and share their learnings from FDA's recent public workshop. Read the white paper at https://lnkd.in/e5EEJcNB
Recent changes to Japan's regulatory requirements for All Case Surveillance (ACS) show progress toward ongoing efforts to address drug lag and streamline Japan's regulatory process.
This week’s ELIQUENT INSIGHTS: Learn how recent revisions to Japan’s post-marketing surveillance regulations are optimizing the country’s regulatory process. Read the IQ Analysis at https://lnkd.in/e7Yq3msJ
