Thought Leadership

At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.

We call it Thought Leadership.

Articles and White Papers

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All expertise Oncology Vaccine Immunogenicity HTA In-Vitro Diagnostics Non-Clinical Cell and Gene Therapy Biostatistics Cardiology ATMP Rare Disease Market Access CMC Clinical Paediatric Acceleration Strategies Medical Devices Quality Patient Safety
14-11-2023

Ensuring Quality and Compliance: Foundational Principles for Drug Development

In this whitepaper, Helen Kargaryani, Global Head of Quality at NDA outlines foundational principles for regulatory compliance, emphasizing Quality Management Systems and Good Manufacturing Practices
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07-10-2020

Remote Audits – The new normal

In this whitepaper, we will provide tips and good practices for remote audits as an alternative method to conducting a traditional on-site audit.
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22-05-2020

Potential Consequences of SARS-CoV-2 to ongoing clinical programs

In this white paper, NDA’s Dr Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.
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