Antonella has been with NDA since 2017 and specialises in helping clients across a wide range of procedures and interactions with the EU regulatory authorities. Her skills allow her to successfully play both a strategic and a more operational role to support the client’s needs.
Key Areas Of Expertise
- Extensive experience in designing and executing regulatory strategies, focusing on the EU market, and overseeing international filings including Swiss applications
- Early and late stage development of small molecules, biologicals, orphan and non-orphan medicinal products
- Regulatory roadmaps
- EMA and national Scientific Advice procedures
- Orphan application designations
- Paediatric development, PIP/waiver strategy and authoring
- Clinical trials
- MAAs submission to approval
- Life cycle management, new indications and variations
- Managing, preparing, and finalising quality regulatory documents, including gap analyses (small molecules)
- Leading cross-functional submission teams
- Interaction with Regulatory Authorities
Before joining NDA, Antonella held EU and International Regulatory Affairs positions at Baxter, Helsinn Healthcare, Addex Pharmaceuticals and Shire. Gaining 18 years experience across all stages of product development and life cycle management in renal, gastrointestinal, hematological, metabolic disorders, CNS and cancer supportive care therapeutic areas. Antonella has a degree in Pharmaceutical Chemistry and Technology.