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.
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.
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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