Gunilla has been with NDA since 1999 and her focus is on CMC, covering the entire life cycle of medicinal products, from early development through clinical studies, marketing authorization applications and post-authorization activities.
Key Areas Of Expertise
- Extensive expertise in CMC documentation, Module 3 and Module 2.3, at all levels of development, including IND, IMPD, NDA and MAA
- Authoring and compilation of CMC documentation for e.g. IND/IMPD/NDA/MAA
- Evaluation of CMC documentation, e.g. gap analyses
- Experience as an agency assessor on national and European level
- Regulatory and strategic advice in pharmaceutical development
- Ph. Eur. Expert in Group 12 on Dosage forms and pharmaceutical technical procedures and member of the Swedish Pharmacopoeia Committee
Gunilla worked as a pharmaceutical assessor at the Swedish Medical Products Agency (MPA), for 12+ years, progressing up to Senior Pharmaceutical Assessor. She was participating as a national expert in CHMP and Working Party meetings at the EMA.