Regulatory consulting

Regulatory Thinking

Rationale
Digital evolutions, future technologies and new manufacturing methods that promise unimagined freedom in design and development, but also in production and distribution, software to be used as medical application or artificial intelligence as part of in-vitro diagnostic devices or new development approaches for medicine and/or vaccines often inspire bold ideas:

Personalized medicine and vaccines, production of customized implants applied directly in the operation room, combination of artificial and biological materials, tissue printing up to the printing of whole organs, virtual reality in rehabilitation, software as decision maker, in-vitro diagnostic devices in a home-care setting, artificial intelligence in diagnostics and/or software algorithms to sustain clinical evidence.

Regulations and legal texts such as standards and norms and/or the various regulations are not written to anticipate safety and performance and/or efficacy requirements for future technologies and applications but attempt to describe what is already established in a set of regulations.

New innovative technologies may not be reflected in the current guidelines. To ensure that new and innovative technologies can be used in the treatment of patients, it is most important to know exactly the applicable standards and laws including their limitations.

Only in this way it can be ensured that the „spirit“ of the underlying regulation is adhered to, even in the case of new, innovative and promising technologies, and that the requirements of the regulations and laws are also adapted and applied to new technologies and methods in their “original sense”.

Questionnaire / Request

The Process
The RegulatoryExperts provide detailed support, advice and teaching to include regulatory thinking for at first internal ETH research groups, spin-offs and start-ups (entrepreneurs) and in a later phase to external start-ups. The level of interaction will be mutually decided after an initial assessment through a regulatory thinking Download questionnaire (PDF, 249 KB) (PDF, 249 KB) followed by a triage type conversation. For internal research groups, spin-offs and start-ups this first assessment is free of charge. The follow-up steps which would involve the advice of the Regulatory Experts will be charged. These latter services are defined by the outcome of the assessment.

Services Medical Devices / In-vitro Diagnostics

Consulting including general advice, hands on service, project membership and review of documents in:

• Development planning incl. milestones setting
• Pre-​assessment of technical documentation
• Pre-​clinical development
• Clinical development
• Analysis of regulatory/notified body compliance
• Timing and support in interacting with regulatory authority/notified body
• Obtaining ethical clearance for human research projects
• Performing human research projects according to legal, ethical and good clinical practice requirements
• Risk management
• Product safety / materiovigilance
• Workshops

Services medicinal product development

Consulting including general strategic advice, hands on service, project membership and review of documents in:

• Development planning incl. milestones setting
• Pre-​clinical development
• Clinical development
• Obtaining ethical clearance for human research projects
• Performing human research projects according to legal, ethical and good clinical practice requirements
• Analysis of regulatory compliance
• Aiming and support in interacting with regulatory authority (e.g. Scientific Advice)
• Regulatory document preparation
• Expedited pathways for medicinal product submission
• Medicinal product quality
• Risk management
• Product safety / pharmacovigilance