By Your Side
From First Data to
Regulatory Approval
Alexandra Günzl, PhD
Independent Non-Clinical Consultant
Clear Strategies. Reliable Guidance. Real Partnership.
Practical scientific and regulatory support - tailored to your product, your development stage, and your team.
Non-clinical drug development and regulatory requirements can be complex and feel overwhelming, particularly in early development, where strategic decisions have lasting impact.
Unclear strategies, fragmented responsibilities, or misaligned documentation can lead to delays, additional costs, and avoidable regulatory risk.
I support pharmaceutical companies and biotech startups in designing and executing non-clinical development strategies aligned with regulatory requirements. Working closely with your team, I ensure that non-clinical data packages are scientifically robust and structured to support well-substantiated Authority submissions – with a clear focus on feasibility, compliance, and efficient progress toward your next milestone.
Services in Detail
Comprehensive non-clinical development and regulatory strategy services for biotech and pharmaceutical companies.
My core services include the following. Additional project-specific needs can be discussed individually.
Product-Tailored Non-Clinical Development
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Gap analyses of non-clinical datasets
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Design of smart, streamlined non-clinical programs
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CRO selection
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non-GLP and GLP study support: strategic protocol design, study oversight and report review
Expert Statements & Risk Assesments
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Expert statements & toxicological risk assessments for e.g., excipients, impurities
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Gap analyses & due diligences of non-clinical datasets
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Environmental risk assessments (also for genetically modified organisms (GMO))
Regulatory Support
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Early regulatory strategy
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Interactions with regulatory agencies
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Scientific Advice meetings: strategic preparation of briefing packages, coordination and moderation of agency interaction
Speaker & Presenter
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Presentations
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Workshops
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Trainings - tailored to your needs
Scientific & Regulatory
Writing
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Briefing documents
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Investigator’s Brochures (IBs)
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Investigational New Drug Dossiers (INDs) (2.4, 2.6)
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Common Technical Documents (CTDs) (2.4, 2.6)
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Biologic Evaluation Reports (BERs) (for substance-based medical devices)
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(Non-GLP) study reports
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Scientific publications
Experience & Expertise
Broad scientific and regulatory experience across diverse product types, indications, and administration routes.
Successful development requires more than regulatory knowledge. It requires an experienced partner who understands the science, speaks the regulatory language, and integrates seamlessly into the team — from first data to submission.
I have extensive experience supporting non-clinical development and regulatory strategy across a broad range of therapeutic modalities, including:
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Small molecules
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Biotechnology-derived products (including monoclonal antibodies, recombinant proteins, peptides, antibody-like molecules)
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Advanced therapy medicinal products (ATMPs) / cellular and gene therapies (CGTs), with particular expertise in cell-based therapies
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Radiopharmaceuticals
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Substance-based medical devices
I have worked on programs …
… across a broad range of therapeutic areas & indications, including:
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Oncology (solid tumors, hematologic malignancies)
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Rare and orphan diseases
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Immunology and inflammatory diseases
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Infectious diseases
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Hematology
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Ophthalmology
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Cardiovascular diseases
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Endocrinology and metabolic diseases
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Pulmonology
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Dermatology
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and others
… developed for multiple routes of administration, including:
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Systemic (intravenous, subcutaneous, intramuscular)
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Oral
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Ocular
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Intranasal
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Inhalation
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Dermal
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Intradermal
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Intratumoral
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and additional product-specific approaches
… and support clients across all stages of non-clinical development — from designing product-tailored non-clinical testing strategies to preparing documentation for regulatory submissions.
About Me
Expertise You Can Rely On.
Partnership You Can Trust.
I am a non-clinical consultant with more than 15 years of experience supporting pharmaceutical companies and biotech startups across diverse therapeutic modalities including:
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Small molecules
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Biotechnology-derived products
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Advanced therapy medicinal products / cellular and gene therapies
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Radiopharmaceuticals
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Substance-based medical devices
With a strong scientific background and a hands-on approach, I work closely with teams to design non-clinical strategies that are scientifically sound, regulatory-compliant, and tailored to each product and development stage.
I combine scientific rigor with pragmatic flexibility to help development programs move forward efficiently, collaboratively, and with full commitment.
Alexandra Günzl, PhD
Independent Non-Clinical Consultant
FAQs
Client questions about working with an independent non-clinical consultant
News
Upcoming and Past Presentations & Workshops
Upcoming Presentations:
Upcoming presentations will be announced
Past Presentations:
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PHARMIG Network Meeting Arzneimittelzulassung: Environmental Risk Assessment – Current Insights and Future Perspectives (June 2026)
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Seminar as part of Toxicology Course Vienna (Medical University of Vienna): General overview of regulatory requirements in drug development (2025)
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Forum • Institute of Management GmbH: CTD: requirements for non-clinical / clinical modules and eCTD-readiness (in 2024 and 2025)
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Forum • Institute of Management GmbH: PharmaFORUM Webcast Biologics 2024: Creation of Non-Clinical Sections of the CTD: Requirements and Practical Insights for Modules 2.4 and 2.6 and the Underlying Data in Module 4
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Forum • Institute of Management GmbH: PharmaFORUM Webcast Biologics 2023: Questions at the interface of CMC and non-clinics - how to contribute to successful non-clinical drug development
Client Voices
What Clients Value About Working With Me
Selected testimonials from pharmaceutical and biotech partners