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Your guide to drug-device authorization

Preparation of documents relevant for medical devices as well as drug component (eCTD) according to relevant regulations.

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.

Abstract classification
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.

Simplification
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.

Golden Gate Bridge
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.

Injecting Epinephrine

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.

Together with our clients, we have repeatedly and successfully addressed these complexities for various combinations. 

Classifiation

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.

Man jumping over a gap
Image by Owen Beard

Expertise through the complete technical documentation

Information related to medical devices must adhere to the MDR 2017/745 regulations and should, at a minimum, include the essential documentation as outlined in Annex I.

  • Molecule classes
    We can support you with our expertise across the full spectrum of drug development: from small to large molecules, biologics to oligonucleotides and more.
  • Development stages
    TODO
  • Species selection
    TODO
  • Technologies
    e.g. silencing novel approaches?

Frequently asked questions

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