Expert support
A reliable expert at your side
We understand the complexities of regulatory pathways and the critical importance of scientific integrity in this field. After two decades of experience, we are proud to be the trusted partner of over 180 industry leaders and innovators.
Fresh ideas
Due to our helicopter perspective and experience, we can bring fresh ideas and innovative approaches that have proven successful before.
Instant clarification
Instant access to solutions for regulatory, scientific, strategic, or process-related issues significantly accelerates the completion rate of projects.
Objective perspective
As external consultants, we offer an objective perspective that can be crucial in spotting issues and opportunities that internal staff, often too close to the project or organization, might miss.
Expert support
Where our experts excel
Regulatory strategy & compliance
Guidance on meeting regulatory requirements and strategies for successful submissions to regulatory bodies.
Product safety & toxicology
Evaluating and mitigating risks associated with the use of products to ensure patient safety and product efficacy.
Study design & support
Expertise in planning and executing clinical trials, biocompatibility evaluation & testing, ensuring scientifically sound and compliant study designs.
Product development
Allowing a clear regulatory pathway concept beginning at the conceptualization stage for the smoothest possible submission.
Expert support
Digital health
With the growing importance of software in or as medical devices, including AI and machine learning, our consultants provide guidance on software development including DiGA (digitale Gesundheitsanwendungen), validation, and compliance with relevant standards and regulations.
Frequently asked questions
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Molecule classesWe can support you with our expertise across the full spectrum of drug development: from small to large molecules, biologics to oligonucleotides and more.
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Development stagesTODO
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Species selectionTODO
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Technologiese.g. silencing novel approaches?
