Customer account
Document sans nom
 
  Untitled Document
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
 
 
CONSULTING
 
 
 
Strategic decisions
Definition of development and registration strategies according to national and EU regulations,
Non-Clinical and Clinical Regulatory Strategy: Clinical programs and protocols assessment (with our partner ),
Decision-making assistance before acquisition of a product or a dossier,
Pharmaceutical, pharmaco-toxicological and clinical dossier audits,
Hot-line contracts: Answer to your questions, in real time, on all topics in relation with pharmaceutical development or regulatory affairs.
 
Consultancy and Quality action plan (with our partner)
Upgrading of production sites to cGMP – FDA standards,
Restructuring the quality structure according to the cGMP criteria,
ICH Q10 Quality Management system compliance,
Implementation of Quality Risk Management:
  Policy
  Risk analysis tools
Drawing up and improvement of your deviations and CAPA process,
Support and advice before, during and after regulatory inspections (Europe and US competent authorities):
Preparation and coaching, Drawing up and submission of action plans, justifications reports, rationale…,
Back-room presence and assistance, Authorities answers drafting…
Follow-up of Site Master File,
Achieving your Product Quality Reviews,
Drafting of URS (internal use or for external companies),
Specification book drafting or translation,
Implementation of double sourcing process,
Documentary system improvement,
Documents storage organization,
 
Formatting of production batch record,
SOPs, instructions and records drafting,
Quality manuals drafting,
Quality indicators selection and improvement,
Design and development of your personnel qualification processes: Trainers and internal tutors, Sample collectors, Clean room operators (clothing, cleaning, technical interventions…),
Creation of job description documents.
 
Untitled Document
FOCUS ON...
BIOWAIVERS WORKSHOP
Séminaire de 2 jours utilisant une approche pragmatique. Ce séminaire de niveau intermédiaire est conçu pour les personnes qui ont déjà une certaine connaissance du développement pharmaceutique et des aspects réglementaires de l'enregistrement des dossiers. Il est destiné aux personnes des services Affaires réglementaires, Développement galénique, Développement clinique, ainsi que Gestion de projets et Business developpement.
28 - 29 SEPTEMBRE 2017
Villa Modigliani - Paris – France
Plus de détails...
FOCUS ON...
PHARMACOKINETIC WORKSHOP
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.
11th – 13th October 2017
Villa Modigliani - Paris – France
More detail...
FORMATION CONTINUE
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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PARTNERS
Audits, Formations
& Consulting
Solutions in Drug Development
Formation
& Edition
Market
Access
Audit, Conseil Formation PhilippeLadure.SAS
conseil-avis-expertise
 
INSCRIPTION
 
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