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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,
 





medical market consultant, pharmaceutical laboratory consultancy

Pharmaceutical development , consultant, pharmaceutical laboratory consultancy

Non-clinical development, consultant, pharmaceutical laboratory consultancy

clinical development study trial consultant

Drug safety and pharmacovigilance, consultant, pharmaceutical laboratory consultancy

paediatric investigational plans pip

Drug dossier submission, authorities registration files ctd

medical market access support



In the last decades, the need to facilitate children access to new medicinal products has considerably influenced drug development. Physicians and drug agencies have stressed the need for children to have access to new treatments adapted to their age, weight, and physiological development.

Drug development in the paediatric population is therefore an important challenge to the pharmaceutical industry due to additional constraints to the overall plans, mainly in the non clinical and clinical programmes, drug formulation and overall planning.

We assist you identify pediatric needs that could be fulfilled with your medicinal product, through the analysis of available marketed drugs and their positioning.
We help you write and produce appropriate pediatric investigational plans (PIP) through the analysis of the disease epidemiology and pediatric needs.
We advise you on age-adapted drug formulation and dosages consistent with Regulatory Authorities and physicians expectations.
We help you develop and write pediatric clinical protocols to be submitted as part of a PIP or a paediatric-use marketing authorisation (PUMA) or following an FDA Written Request.
We help you identify key experts in the field of interest and constitute advisory boards, data and safety monitoring boards (DSMB) for the supervision of your pediatric clinical trials.

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




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


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