Anaïs Tinard Duluc

Anaïs Tinard Duluc

Consultant Regulatory Affairs

Key Knowledge Areas:

  • Development and Registration 
  • Renewal, MA Variations 
  • Risk Minimization plan documents 
  • Packaging material review 
  • Early Access Program (ATU) 
  • Project Manager France RMS 
  • Clinical Trial Application  

Contacter

Education 

Anais earned a PharmD at the University of Pharmacy Bordeaux (2008) and has a master’s degree in International Drug Development and Registration from University Paris 11 (2009).

 

About Anaïs

Anaïs has extensive expertise in regulatory affairs including development and registration activities for medicinal products gained through her several position in the pharmaceutical industry over the last 10 years.  

Anaïs has been involved in various regulatory projects assisting start-up to international companies as Regulatory Affairs Consultant.  

Background/ Past Experience 

Prior to joining Bluereg, Anaïs worked for several companies such as Ipsen and Novartis in Paris as European registration/ Clinical trials Pharmacist dedicated to transplantation, ophthalmology and neurology therapeutic areas.  

 

Anaïs worked at Novartis Pharma France for 9 years and was in charge of registration activities (mutual recognition and centralized procedures): variations, renewals, risk minimization plan documents, Support on ATU regulatory activities; packaging material review. During her experience at Novartis, Anaïs was also in charge of clinical trials applicationsPreparation, submission and follow-up of initial application and amendments to French Health Authorities.  

 

In 2020 Anaïs moved to consultancy and joined BlueReg as Regulatory Affairs Consultant in Paris.