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Together with you, IASON consulting develops tailor-fit authorization strategies to fit your needs and accomplish your targets.
IASON consulting combines competent scientific advice alongside with regulatory consultancy and document creation - all under one roof. Our experienced experts are happy to assist you immediately and personally.
Preparation
When it comes to regulatory meetings, preparation is everything. Prior to scientific advisory meetings and during a rehearsal, IASON consulting provides you and your project team with the background knowledge necessary to find an appropriate reply to any question.
Execution
If requested, IASON consulting attends advice meetings with Medicines Agencies worldwide or with your Notified Body and supports you directly at the agency.
Documents for Drugs
Preparation of Electronic Common Technical Documents (eCTD), Investigational Medicinal Product Dossiers (IMPD) and Investigator’s Brochures (IB), etc.
Clinical Documents for Devices
Clinical Evaluation Reports (CER), Clinical Evaluation Plan (CEP), and Post-Market Surveillance Plan (PMS Plan) in compliance with MEDDEV 2.7/1 rev. 4.
Product Specific Advice
Professional literature searches and expert summaries, advice on whether a study must be performed according to the project’s clinical phase and other ad-hoc consultancy.
Biocompatibility
Biocompatibility Assessments (Biological Safety Evaluation) according to DIN EN ISO 10993 Biological Risk Assessments (BRA), and Risk Analyses (RA) for technical documentation.
EU, US and National Agencies
Scientific briefing packages for small molecules, protein/peptide drugs, generics/biosimilars, herbal medicinal products, homoeopathic remedies, or novel excipients, oligonucleotides etc.
GAP Analysis
Expert check of your documents with respect to national and international regulatory requirements for drug* and device** development.
* according to EMA guidelines; FDA guidelines; ICH guidelines etc.
** according to DIN EN ISO 10993.
Regular updates for all regulatory documents required for a dossier.
Regular updates for all regulatory medical device documents.
Scientific support for breakthrough substances.
Pre-authorisation advice.
Scientific assessments for new indication(s).
Literature based support of marketing strategy.
Professional market screening for potential comparator products.
Contact us now for more information!