Patrizia Nestby, PhD, MSc (Regulatory Affairs)

Independent Regulatory Affairs Consultant

Effective regulatory affairs requires more than knowledge of the regulations. It requires a clear understanding of the science, the evidence and the context in which decisions are made.

My role is to help biotechnology and pharmaceutical companies navigate important regulatory challenges by identifying what truly matters, recognising regulatory opportunities, and translating scientific and regulatory evidence into clear strategic direction.

With more than 28 years’ experience in regulatory affairs, I have led regulatory strategy across the product lifecycle in both industry and consultancy. My experience spans innovative medicines, rare diseases, paediatric development and regulatory interactions with major health authorities, including the EMA, MHRA and FDA.

I combine strategic leadership with hands-on regulatory support, working directly with multidisciplinary teams to develop regulatory strategy, prepare and review high-quality regulatory documentation, and support programmes from early development through marketing authorisation and lifecycle management.

Whether developing regulatory strategy and executing corporate goals or preparing key regulatory documentation, the following principles underpin my approach: understanding the evidence, identify what truly matters, recognise regulatory opportunities, and communicate with clarity.