Bookmark and Share

Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,

Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,
Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,
  pharmaceutical industry consulting in France, pharmaceutical laboratory consulting, drug safety, clinical study, medical market consultants, scientific communication consulting,
 






Heathics Paris France, pharmaceutical industry consultant, pharmaceutical laboratory consultant team,  study, trial, consultant, paediatric investigational plan, registration files ctd,


Experience

Since it was founded in 2008, HEATHICS has contributed to drug development and regulatory strategies for several pharmaceutical companies. Assignments were succesfully completed in a variety of domains:
  • Early assessment of Clinical Development Plans and recommendations in line with Regulatory Strategy and Product Positionning.


  • Clinical Study outline and protocol development


  • EMA Paediatric Investigational Plans (PIP)


  • Registration files: development of Common Technical Documents (Summaries and Overviews) for New Chemical Entities, Type II variations, Well Established Medicinal Use, orphan indications.


  • Labelling optimisation, Medical Communication and publication plans (abstracts and manuscripts for publication)


  • Pricing and reimbursement procedure in France (Transparency Dossier): 'Note d'Intérêt Thérapeutique'


  • Review and optimisation of advertising and promotional materials






Heathics
111, rue des Tennerolles - 92210 Saint Cloud, France
Phone/Fax : 33+ (0)1 46 02 19 30.


Links


Conception - réalisation
lagencecdrs.com