Our Experts

At NDA we’re a team of experts – experts in the regulated disciplines, and experts in drug development.

Some of us have attained our experience from working inside regulatory authorities, carefully assessing the benefits and risks of new treatments. Some of us have worked for years in the biotech and pharmaceutical industry, patiently developing life changing products for patients suffering from debilitating and sometimes deadly diseases and conditions.

Whatever our background, we share a passion for the art and science of drug development and for making a difference to the clients and the patients we ultimately serve.

Get to know the people behind the passion – read more about our incredible team below.

All services Development Strategy Medical Devices Pharmacovigilance Strategic Communications Regulatory Quality & Compliance NDA Advisory Board
All expertise Oncology Vaccine Immunogenicity HTA In-Vitro Diagnostics Non-Clinical Cell and Gene Therapy Paediatric Clinical CMC Market Access Rare Disease ATMP Cardiology Biostatistics Acceleration Strategies Medical Devices Patient Safety Quality Bioanalysis
01-10-2020

Antonella Cominetti

Senior Consultant
Expert in regulatory strategies for the European and Swiss markets
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13-07-2023

Dr Albert L. Kraus

Advisory Board Member 
Expert in in regulatory sciences and global medicine development
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11-03-2024

Dr Karl-Heinz Huemer

Advisory Board Member 
Expert in Scientific & regulatory strategy
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01-10-2020

Dr Laurie Smaldone Alsup

SVP Regulatory Science
Expert in clinical development and regulatory strategy
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01-10-2020

Dr Margaret Mitrane

Advisory Board Member
Expert on FDA drug and biologics approval processes
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01-10-2020

Dr Pieter Neels

Advisory Board Member
Expert knowledge of vaccines and evaluating new medicinal products
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10-10-2022

Elizabeth Fenna

Principal Consultant
Expert in drug development and life-cycle management strategies.
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01-10-2020

Kimberley Forbes-McKean

SVP Regulatory & Strategy US
Expert in global clinical and regulatory strategies
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Contact Us

Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

Let's Bring Medicines to the World

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