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Mastering the safety equation

Be confident that Health-Based Exposure Limits (HBEL) are calculated right and include all necessary safety, quality, and regulatory aspects. 
1-to-1 cooperation

Meet your consultant in an online meeting to ensure that our consultant deeply understands your need and vision. 

Letter, pen and envelope
Corporate template

We will be happy to respect your corporate template to ensure that our HBEL documents will be fit your corporate formatting and style requirements. 

Clear communication

From the initial consultation to project completion, we prioritize clarity and transparency to ensure your needs are understood and met at every step.

HBEL contents

Leave content management and compliance requirements to us - this way you can focus on your specialized work.

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Risk assessment

HBELs are based on a thorough risk assessment of the potential exposure to a particular substance, such as an active pharmaceutical ingredient (API) or an excipient. This assessment considers factors like the toxicity of the substance, the intended patient population, the route of administration, and the duration of exposure. It's crucial to conduct a comprehensive risk assessment to determine the appropriate limit that will ensure patient safety.

Regulatory compliance

HBELs must align with regulatory guidelines and standards set by health authorities such as the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency).


Compliance with these regulations is essential to ensure that pharmaceuticals and medical devices meet the required safety standards and gain marketing authorization. HBELs should also consider international guidelines, such as the ICH, when applicable.


Product characteristics

HBELs should be specific and tailored to the characteristics of the product in question. This means that the limit should consider the unique properties of the substance, the intended use of the product, and the patient population it serves. HBELs are not one-size-fits-all; they need to be customized to each product to account for variations in risk and exposure.

Frequently asked questions

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  • 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
  • Species selection
  • Technologies
    e.g. silencing novel approaches?

Request a quote

We will be happy to answer any questions you might have via e-mail or in a free online kick-off meeting. 

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