Preclinical Strategy & Development Team

The development of both, medical devices and medicinal products, is heavily related to verification activities to ensure that respective products are developed right in the sense of meeting specification and in regard to be compliant with regulatory requirements.

In this context, we are engaged to deliver solutions and services which include for:

Medicinal products

• Planning and support of preclinical studies
• Preparation of the CTD modules: (1) 2.4 Non-Clinical Overview, (2) 2.6 Non-Clinical written and Tabulated Summaries, (3) 4 Non-Clinical Study Reports
• Toxicological evaluations of active ingredients, excipients, and impurities
• Evaluation of active substances contained in medicinal products, which may have harmful environmental effects
• Gap analysis of existing documentation against regulatory requirements
• Support in scientific consultation procedures (EMA, national competent authorities)
• Systematic literature searches
• Due diligence for in-licensing candidates

Medical devices and combination products

• Supervision of design control activities in the context of design verification including preparation of the associated technical documentation
• Describing or defining the (primary) Mode of Action (pMoA)
• Classification of medical devices based on the (p)MoA
• Advising on the formulation of substance-based medical devices from a development and regulatory perspective
• Preparation of biocompatibility documentation (Biological Evaluation Plan and Report)
• Preparation of design verification plans, if required, also in cooperation with accredited laboratories including method validation and preparation of corresponding reports, e.g. for biocompatibility, storage stability, cleanliness of medical devices

The team is composed of scientists with extensive academic experience in veterinary medicine, toxicology, biochemistry, molecular medicine, and microbiology. In addition, the team members have also gained many years of experience in various positions in industry.

Consequently, the team is well qualified and has extensive experience to be able to help clients in the exciting and varied field of preclinical development for medicinal products and design verification for medical devices). Given their broad experience, the team members can work in a flexible and solution-oriented way from different perspectives to creatively identify tailor made solutions.