Preclinical Development: The Foundation of Innovation

Safety and Efficacy: The Pillars of New Therapies

The regulatory requirements for medicinal products as well as for medical devices are becoming increasingly demanding. At the same time, efforts to harmonize the approval procedures for these products are intensifying. Due to political developments, such as Brexit and the potential ending of the Mutual Recognition Agreement between Switzerland and the EU, a diversification of requirements is taking place in parallel.

In this context, it is good news that there is a joint basis on which not only medicinal products and medical devices, but also regulatory requirements can be addressed similarly.

These are mainly preclinical activities in the pharmaceutical field or design verification activities for medical devices, i.e. scientific methods to demonstrate the safety and performance of these products.

Our services include:

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 potentially harmful environmental effects of active substances contained in medicinal products (EMEA/CHMP/SWP/4447/00 Corr 2)
• Gap analysis of existing documentation against regulatory requirements
• Support in scientific consultation procedures (EMA, national competent authorities)
• Systematic literature searches
• Writing of scientific articles for publication
• 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
• Regulatory assessments and gap analyses for project evaluations with a focus on design verification
• 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
• Due diligence for in-licensing candidates

Book an appointment with Dr. Nicolas Gengenbacher