Service
Based on my professional experience, I would like to offer you the following services:
Medical Writing
Preparation of documents related to clinical trials, e.g. CSPs, CSRs, ICFs, IBs, IMPDs.
Publication Writing
In the biomedical field, writing of scientific evaluations or publications (original research papers, posters, presentations or review articles) based on scientific literature and/or scientific data.
Dossier parts for your application for marketing authorization:
- Nonclinical: Module 2.4 (Expert Statement), 2.6 and Module 4
- Clinical: Module 2.5 (Expert Statement), 2.7 and Module 5
- Pharmaceutical quality: Module 2.3 and Module 3 (including Dossier life-cycle management)
- Forms etc.: Module 1
- or equivalent Vet Dossier parts
Gap analysis of existing dossiers or dossier parts - checking for content-related completeness.
Novel Food Dossers
Dossier writing according to the current EFSA regulations.
Including foods with new/modified molecular structure, foods consisting or derived of microorganisms, fungi, or algae, cell or tissue culture, insects, plants and plant parts, minerals, traditional foods, and foods from new production processes.
Including intake assessments.
Consulting
Presentations and customer workshops
Negotiations and communication with regulatory authorities
Communication and networking with key opinion leaders, industry partners, CROs, contractors, etc.
Development of product-specific regulatory strategies
Scouting – search for innovative products, ingredients and delivery forms
Contract design and verification according to customer-specific content-related aspects