Experienced in both worlds
As a consulting firm specializing in both pharmaceuticals and medical devices, we are uniquely qualified to handle complex drug-device initiatives that require a high level of expertise.
Classification
The classification of a product plays a pivotal role in determining its regulatory pathway. Finding the right path for borderline product is essential for a smooth market authorization.
Strategic alignment
Ensuring alignment between the device and drug components in terms of regulatory strategy, labeling, and risk management is vital. A consultant overseeing both parts can develop a more coherent and strategic approach.
Bridging regulatory
Being well-versed in both device and drug regulations, we can provide a more holistic understanding, ensuring that your submission meets all relevant requirements.
Classifying borderline products - but right!
Determining the regulatory category for products that blur the lines between medical devices and pharmaceuticals is a complicated task. Such products necessitate thorough assessment to establish the appropriate regulatory pathway.
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Together with our clients, we have repeatedly and successfully addressed these complexities for various combinations.
Our experience in eCTD compilation
An Electronic Common Technical Documentation (eCTD) is mandated for presenting drug-related information, offering the drug-specific data in a uniform format.
Besides advising on medical devices, providing assistance for pharmaceuticals constitutes one of the two pillars of our everyday operations.
Frequently asked questions
