Nicola Gonzalez-Swan

Nicola has over 15 years’ experience in the pharmaceutical industry encompassing QC, analytical method development and regulatory affairs. Her main area of expertise is Chemistry, Manufacturing and Control (CMC).

Nicola has expertise in European regulatory affairs, particularly with Module 3 audits, gap analysis and upgrading. Investigational Medicinal Product Dossiers (IMPD’s) compilation, CMC deficiency letters and life cycle management.

Nicola holds a BSc in medicinal chemistry and MSc in Analytical chemistry and has in depth knowledge of CMC involved with allergen immunology products along with analytical method development and validation. Nicola has knowledge of European regulatory requirements and hands on experience within a manufacturing environment.