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Regulatory Affairs

Pre-Agency preparation meetings & inhouse portfolio review processes

All In One - Marketing Authorisation

Science. Regulation. Market.

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 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.

Execution

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.

Regulatory Solutions

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.

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.

Post-Authorisation Services

Renewals

Regular updates for all regulatory documents required for a dossier.

Recertification

Regular updates for all regulatory medical device documents.

Fast Track Approval Applications

Scientific support for breakthrough substances.

Scientific Advice

Pre-authorisation advice.

Life Cycle Management

Scientific assessments for new indication(s).

Claims

Literature based support of marketing strategy.

Competitor Searches

Professional market screening for potential comparator products.

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