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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



Submission of a registration dossier cannot be considered without a well defined and validated Regulatory Strategy which includes key components such as compliance with Scientific Guidelines as long as they are available, documentation of competitive claims and product positioning, consideration of the product lifecycle in view of sequential developments, submission priorities and planning, opportunities for accelerated or simplified procedures and interactions with Health Authorities.

We assist you in establishing productive communications with Health Authorities (French and/or European Agency Consultation, Scientific Advice, Clarification Meetings, Oral Explanation). This includes coaching and assistance in meeting preparation, rehearsal, slide set generation and active participation upon request. Communication with Health Authorities helps the validation of the Regulatory Strategy, especially in situations when appropriate scientific guidelines are not available or existing ones must be negotiated.
Whatever the regulatory types and/or procedures, all have in common the need to complete submission dossiers according to the CTD format.
We write the different components of the CTD (integrated clinical summaries and overviews) in a 'friendly reader' manner with the purpose of facilitating the evaluation with concise presentation of the data in the summaries and relevant discussions in the overviews.
We develop the Summary of Product Characteristics (SPC) with the purpose of optimising both efficacy and safety label claims.
We handle the Questions-and-Answers process at each step of the evaluation procedure.

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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Conception - réalisation
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