Medical Devices and Combination Products
Strategic development and regulatory support.
Comprehensive technical documentation and risk management.
Borderline Classifications, Notified Body Opinions.
Precision medicine
Bespoke regulatory strategies for biomarker-driven clinical trials.
Regulatory submissions for CDx and targeted therapies.
Advanced therapy medicinal products (ATMPs).
Human Factors Engineering
Design, optimization, and validation of user interfaces and product interactions in line with Design Controls, regulatory requirements and safety standards to ensure usability and patient safety
Packaging Development
End-to-End Packaging Development.
Optimization and Harmonization.
Sustainability and Life Cycle Thinking.
