Nicola Gonzalez-Swan

Nicola has over 15 years’ experience in the pharmaceutical industry encompassing QC, analytical method development and European regulatory affairs. Her main area of expertise is in Chemistry, Manufacturing and Controls (CMC), particularly Module 3 writing, gap analysis and upgrading, IMPD compilation, deficiency letter responses and life cycle management. Nicola has in-depth knowledge of the CMC aspects of allergen immunology products, including analytical method development and validation.

She holds a BSc in medicinal chemistry and MSc in Analytical chemistry. Nicola has knowledge of European regulatory requirements and hands on experience with in a manufacturing environment.