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.
When it comes to regulatory meetings or events with regulatory personnel, preparation is everything. Prior to scientific advisory meetings or regulatory audits / inspections and during a rehearsal or pre-audit evaluation / pre-inspection audit, IASON consulting provides you and your project team with the background knowledge necessary to find an appropriate reply to any question and to achieve audit /inspection-readiness.
If requested, IASON consulting attends advice meetings with Medicines Agencies worldwide or with your Notified Body and supports you directly at the agency and during hosting of regulatory audits or inspections.
Documents for Drugs
Preparation of Clinical Study Reports (CSR) in compliance with ICH-E3, 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.
Preclinical Documents for Devices
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.
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.
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!