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 What are Your Needs?
 Why should You Retain Us?



Caroline Delaitre


tel.: (+33) 1
53 58 57 66

 
  What are Your Needs?
  If you strive to define a strategy and develop your activities according to current and upcoming pharmaceutical regulations: we help you to identify, understand and to comply with technical and regulatory requirements regarding your products and activities

Your health products
 
  Early access program "Autorisation temporaire d'utilisation" (ATU) - cohort or nominative ATU applications
 - Evaluation of the feasibility of such an anticipated access to French market
 - Preparation of the protocol for therapeutic use (PTU)
 - Preparation and compilation of the cohort ATU application
 - Contact with the French Health Authority for cohort or nominative ATU
 - Advice regarding the medicinal products distribution within an ATU program
 
  Registration strategy plan
 - Advice on the European procedure to choose, on how to position the application; confirmation of the eligibility criteria for a centralised procedure etc
 - Regulatory follow-up throughout the procedure (European or national procedures)
 
  MA dossiers for medicinal products (for which a prescription is required, and for OTC)
 - Module 3 of the CTD (quality section), ASMFs and CEP
 - Dossiers to request an exemption from the poisonous medicinal products list and to switch the medicinal products classification to OTC status
 - Preclinical and clinical dossiers (bibliographic synthesis, overview and summaries, posters, and articles)
 - Support to position the variation application and the compilation of the dossier within national procedure, MRP, DCP and CP

Your interface with healthcare professionals and the public
 
  Advertisement : promotional and environmental documents designed for professionals and for the public (all kinds of materials)
 - Regulatory requirements
 - Regulatory risk assessment of the whole documentation
 - Critical analysis of the clinical studies during the elaboration of campaigns
 - Submission of the promotional materials to AFSSAPS
 - Preparation of reliable arguments in case of litigation with health authorities or competitors, in case any issues are raised by them
 
  Interactions with healthcare professionals (anti-gift law, funding)
 - Evaluation of the feasibility of your projects
 - Support the declaration to healthcare professional's boards
 - Support the elaboration of the company policy
 - Critical review or writing of Standard Operating Procedures (SOPs)
 - Audit the compliance of achieved operations
Your regulatory environment
 
  Frequent regulatory intelligence in line with your concerns and analysis of the impact of new pharmaceutical regulations on medicinal products and other health products
  Insight on specific aspects of pharmaceutical regulation, from registration to "exploitation"
Your regulatory and pharmaceutical projects
 
  Technical and regulatory insight on the feasibility or the compliance of a project with current regulations
 - Study on the feasibility of switching the classification of medicinal products
 - Organisation of activities related to pharmaceutical operations (advertising, pharmacovigilance, French medicinal representative charter, etc)
 - License pharmaceutical establishments
 - Analysis of the strategic position of a product within a regulatory status
  Support the administrative steps required to achieve a project
Your investments
 
  Audits and due diligences
 - Pharmaceutical organisation and global strategy
 - Regulatory due diligence on a product or on a global portfolio
   



  Why should You Retain Us?
 
Comprehensive knowledge of healthcare regulation, industry environment and potential changes

Understanding of health authorities' expectations and practical experience of administrative regulatory submissions

Team experimented in industry, with regulatory intelligence techniques and which includes pharmacists, lawyers and research assistants
 


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