Behind The Submissions: Regulatory Experts Share Their Experiences

An engaging discussion with Dr. Laura McIntosh and Dr. Hazel Clay explores how Altasciences’ regulatory and operational teams collaborate to support sponsors across every stage of the drug development journey. As Executive Director of Program Management and Regulatory Affairs, Dr. McIntosh outlines their end-to-end regulatory expertise — from gap analysis and strategic planning to IND/CTA submissions and preparation for regulatory meetings.

Dr. Clay, a scientific advisor in drug development, shares how she partners with sponsors to understand their objectives and translate them into tailored execution plans spanning nonclinical through clinical phases.

Together, they highlight a highly integrated, cross-functional approach that brings together bioanalysis, preclinical, and clinical services. Through real-world examples, they demonstrate how the team helps sponsors overcome complex challenges, whether by designing customized toxicology studies or guiding first-time developers through the full regulatory pathway.

The conversation underscores Altasciences’ agility in adapting to evolving project needs and its strong commitment to ensuring sponsors are well-prepared for key regulatory milestones.