We have joined forces with Immunogenicity Integrated to deliver top immunogenicity consulting services worldwide.
Regulatory Science for Biotherapeutics Development
Expert immunogenicity consulting services that integrates translational biology and product quality (CMC) aspects to promote the development of safe and efficacious biotherapeutics.
LAIZ combines over 15 years of scientific, regulatory, and industry experience to deliver sound advisory services starting at the lead-candidate stage all the way to commercialization and life-cycle management
Immunogenicity Expertise at Regulatory Depth
Supporting global biotech and pharma teams across immunogenicity-critical development milestones — from early risk assessment through marketing authorization.
51+
Immunogenicity Risk Assessments (IRA)
12+
Integrated Immunogenicity Summaries (ISI)
31+
EMA/FDA Scientific Advice Meetings
Experience spanning early development through marketing authorization.
Immunogenicity is not an isolated discipline.
It intersects product quality, clinical pharmacology, and regulatory decision-making. LAIZ integrates these dimensions to support confident development from early risk assessment to regulatory submission and beyond. This integrated perspective is critical for complex biologics and advanced therapies.
Services
Chemistry, Manufacturing, and Controls (CMC)
Strategic CMC frameworks grounded in Quality by Design
We define CMC strategies that identify and manage analytical risks in biologics and advanced therapy medicinal products (ATMPs) early in development. Applying Quality by Design (QbD) principles, LAIZ supports fit-for-purpose analytical methods and robust quality documentation to enable consistent product quality and regulatory readiness.
Immunogenicity Consulting
Risk-based immunogenicity strategy with clinical and regulatory impact
LAIZ advises biotech teams on integrated immunogenicity strategy for biotherapeutics, peptides, and oligonucleotides aligning quality, preclinical, and clinical considerations with regulatory expectations. We define bioanalytical strategies for ADA/NAb evaluation, and immunogenicity risk mitigation to ensure a regulatory strategy that supports meaningful clinical data interpretation.
High-quality regulatory submissions
Clear and integrated presentation of data for efficient regulatory review
LAIZ supports the preparation of high-quality regulatory submissions across the product lifecycle. By integrating immunogenicity, CMC, and clinical data into a coherent narrative, we help facilitate efficient review of regulatory dossiers by health authorities (EMA, FDA and other ICH regions).
Trusted by 80+ clients worldwide since 2020.
Selected clients include:
Global Pharma
Biotech & Emerging Therapies
About
Laura is the founder of LAIZ Regulatory Science and co-founder of Immunogenicity Integrated.
A PhD immunologist with 15+ years across FDA, pharma, and biotech, Laura advises global teams on immunogenicity-critical regulatory strategy for biologics and advanced therapies. Her experience spans regulatory review, industry leadership, and strategic support for complex development programs.