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 is a pharmacist with post-graduate qualifications in pharmaceutical sciences.

Nicoletta started her career in the pharmaceutical industry as an analytical chemist and formulation scientist. These roles provided her with solid foundations in drug development, project management, manufacturing scale-up, quality management systems and validation principles. In her first regulatory role she participated in the transition of the generic industry towards more complex generics and biosimilar products.

As the Global Director of Regulatory Affairs at an Australian company developing a first-in-class orphan drug using a complex dosage form she worked closely with the drug substance and drug product manufacturers, managed part of the Non-Clinical development program and supported the clinical program with the preparation of the US Investigational New Drug (IND) application. Nicoletta managed the Company’s regulatory procedures leading to the approval of the European Marketing Authorisation Application (MAA) and US New Drug Application (NDA).

As a Non-Executive Director in the health sector Nicoletta is committed to public health.

Nicoletta has founded Canary to help bring new treatments to market globally.

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