Customer account
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Your partner in CTD & eCTD files - Variations - Risk Management Plan - Environmental Risk Assessment - Preclinical and Clinical - PIL user testing - CEP and ASMF applications - National and DCP MAs - MA Holding - MA Transfer - ICH Q3D Risk analysis - Reimbursement and prices - Market access studies - Consultancy and Quality action plan - Qualification and Validation - Coaching and Communication - GMP training sessions
Registration activities
Writing of MA dossiers (Modules 1 to 5) under national, centralized (CP), decentralised (DCP) or mutual recognition (MRP) procedures:
• Module 1 specific activities: SmPC, Patient information Leaflet, labeling, PIL User Testing, Environmental Risk Assessment (ERA), Risk Management Plan (RMP)
• Module 2 specific activities: Quality Overall Summary, Non-Clinical and Clinical Overviews, Non-Clinical and Clinical Summaries
Filing of Certificate of Suitability to the Eur. Ph. (CEP) and Active Substance Master File (ASMF)
Electronic submission (CESP, Web client), follow-up of procedures and exchanges with Health Authorities:
• on behalf of our clients (as MA Holder - MA transferred when granted)
• as authorized contact person for our clients
Updating to CTD format, Electronic Submissions (eCTD)
Regulatory maintenance activities
Administrative, Quality and Clinical Variations (including Change of the Product Information "DMI"):
• determination of the variation category
• submission strategy (grouping, worksharing)
MA renewal, MA transfer, change of "Exploitant", Sunset Clause waiver
Therapeutic indications extension
Elementary Impurities risk analysis (ICH Q3D)
Particular medicinal products experience
Herbal medicinal products and medicinal gases
Cutting and formatting of files
Converting files to the required format
Compilation files in eCTD format
Creating hyperlinks
Preparation of draft electronic publication
Validation of the conformity of publication to ensure technical validity
Finalization of the electronic publication for submission
Implementation of new eCTD sequences for variations during life cycle of the product
With our partner
Consulting and writing services of regulatory dossiers in accordance with new EU regulation
Files Quality, Safety and Efficacy (UE format)
Administrative procedures
Follow-up and exchanges with Authorities
Untitled Document
A 3-day intermediate level Workshop using a top-down approach with a strong mechanistic emphasis. This intermediate level workshop is designed for those engaged in pharmacokinetic studies in drug discovery, development and regulatory assessment, who already have a good working knowledge and understanding of the basic physiological and mathematical concepts and applications in the subject area, for example, who have taken the Basic Pharmacokinetic Workshop, Arosa.
10th – 12th October 2018
Villa Modigliani - Paris – France
More detail...
La formation continue, une activité stratégique pour accompagner les entreprises.
L’EBI met à disposition des chefs d’entreprise une offre variée de formations.
Ces stages permettent de développer les compétences de leurs salariés dès le niveau technicien dans les domaines d’expertise de l’EBI : biotechnologie, procédés industriels, formulation, analyse sensorielle, marketing, …
Formations inter-entreprises : l’EBI propose tout au long de l’année des stages d’une ou deux journées (catalogue disponible sur notre site internet).
Formations intra-entreprise : selon les besoins spécifiques de l’entreprise, l’EBI accompagne les entreprises dans l’élaboration de formations sur mesure permettant ainsi de former en interne un petit groupe sur un thème ciblé.
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