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What are Your Needs? |
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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
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Your health products |
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Early access program "Autorisation temporaire d'utilisation"
(ATU) - cohort or nominative ATU applications
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Evaluation of the feasibility of such an anticipated access to French market |
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Preparation of the protocol for therapeutic use (PTU) |
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Preparation and compilation of the cohort ATU application |
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Contact with the French Health Authority for cohort or nominative ATU |
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Advice regarding the medicinal products distribution within an ATU program |
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Registration strategy plan
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Advice on the European procedure to choose, on how to position the application;
confirmation of the eligibility criteria for a centralised procedure etc |
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Regulatory follow-up throughout the procedure (European or national procedures) |
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MA dossiers for medicinal products
(for which a prescription is required, and for OTC)
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Module 3 of the CTD (quality section), ASMFs and CEP |
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Dossiers to request an exemption from the poisonous medicinal products
list and to switch the medicinal products classification to OTC status |
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Preclinical and clinical dossiers
(bibliographic synthesis, overview and summaries, posters, and articles) |
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Support to position the variation application and the compilation of
the dossier within national procedure, MRP, DCP and CP |
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Your interface with healthcare professionals and the public |
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Advertisement : promotional and environmental documents designed for professionals and for the public
(all kinds of materials)
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Regulatory requirements |
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Regulatory risk assessment of the whole documentation |
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Critical analysis of the clinical studies during the elaboration of campaigns |
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Submission of the promotional materials to AFSSAPS |
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Preparation of reliable arguments in case of litigation with
health authorities or competitors, in case any issues are raised by them |
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Interactions with healthcare professionals (anti-gift law, funding)
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Evaluation of the feasibility of your projects |
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Support the declaration to healthcare professional's boards |
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Support the elaboration of the company policy |
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Critical review or writing of Standard Operating Procedures (SOPs) |
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Audit the compliance of achieved operations |
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Your regulatory environment |
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Frequent regulatory intelligence in line with your concerns and analysis of the impact of
new pharmaceutical regulations on medicinal products and other health products
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Insight on specific aspects of pharmaceutical regulation,
from registration to "exploitation"
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Your regulatory and pharmaceutical projects |
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Technical and regulatory insight on the feasibility or the compliance of a project with current regulations
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Study on the feasibility of switching the classification of medicinal products |
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Organisation of activities related to pharmaceutical operations
(advertising, pharmacovigilance, French medicinal representative charter, etc) |
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License pharmaceutical establishments |
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Analysis of the strategic position of a product within a regulatory status |
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Support the administrative steps required to achieve a project
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Your investments |
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Audits and due diligences
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Pharmaceutical organisation and global strategy |
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Regulatory due diligence on a product or on a global portfolio |
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Why should You Retain Us? |
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Comprehensive knowledge
of healthcare regulation, industry environment and potential changes
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Understanding of health
authorities' expectations and practical experience of administrative regulatory submissions
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Team experimented in industry, with regulatory intelligence
techniques and which includes pharmacists, lawyers and research assistants |
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