Amala Saju
Amala Saju is a regulatory affairs professional experienced in Chemistry, Manufacturing, and Controls (CMC) across global pharmaceutical companies, including Pfizer, Novo Nordisk, and currently, Sanofi. Her expertise lies in CMC technical writing focused on pharmaceutical manufacturing processes, quality control, and product specifications to support global regulatory submissions and compliance. She has contributed to over 100 […]
Miriam Guest
Miriam Guest is the Senior Principal Scientific Advisor of Microbial Solutions. She recently joined the organization after 20 years with AstraZeneca. In her role, she provides scientific governance and strategic direction. She has extensive experience in the pharmaceutical Industry leading contamination control strategies for drug development projects as well as supporting internal and external manufacturers […]
Veronika Wills
Veronika Wills, Director of Global Technical Services, Associates of Cape Cod, Inc. is a recognized global subject matter expert on endotoxin and glucan detection with 18 years in the biopharmaceutical industry. Veronika is also an expert on global and local regulatory and guidelines for implementation of traditional LAL methods as well as innovative recombinant technologies […]
Proactive Compliance:
Building Adaptive Quality Systems to Navigate Future Regulatory Landscapes This session covers:
