Nicoletta Muner

Managing Director (MPharmSci GAICD)


Administration, Loyola University

Research Scientist

General and Children’s Health

Regulatory Professional

Apicona Medical Center, Wellington, FL . Family Medicine

Non-Executive Director (Health)

Lorem Ipsum has been the industry’s standard.

Nicoletta founded Canary Regulatory Affairs in 2020 after obtaining market authorisation from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a first-in-class orphan drug as the Global Director of Regulatory Affairs of an Australian ASX listed company.

Under her leadership Canary has guided both Australian and international clients, ranging from innovative entrepreneurs to large private and publicly traded companies, through their development process by ensuring regulatory compliance throughout the manufacturing process, overseeing non-clinical development programs and by contributing to the design of clinical studies, including First in Human (FIH) trials.

Nicoletta has assisted clients in the preparation and filing of US Investigational New Drug (IND) applications and steered them through Scientific Advice meetings with the FDA, EMA and MHRA. Canary’s expertise ranges across multiple therapeutic areas including neurology, oncology, anaesthesiology, dermatology, cell and gene therapies and infectious disease.

Canary embraces a culture of close collaboration with client teams and strives to identify the most pragmatic and cost-effective approaches to overcome development hurdles and deliver tailored regulatory strategies to facilitate market access.

  • Drug Substance ASMF/DMF
  • Product Development
  • GLP Protocols
  • GMP Manufacturing