TOXICOLOGY-AS-A-SERVICE

Access the knowledge of experienced, EUROTOX-certified toxicologists.


Toxicological aspects must comply with a large number of regulations and therefore play an important role in the pharmaceutical industry. At the same time, it can be difficult to keep an overview and take all factors into account.

In cooperation with our partner Azierta, located in Spain, we offer the services below to support you with all your toxicological needs. Access the knowledge and expertise of experienced toxicologists (certified by EUROTOX) for the following services:

PDE Reports

In multi-product facilities it’s essential to know how many residues of a certain substance could technically still be in the used equipment without causing any harm. We determine the Permitted Daily Exposure Limit for any substance and provide you with the according PDE report.

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OEL & API Characterization

To guarantee the health and safety of employees involved in the manufacturing process, it is necessary to determine an upper limit for any hazardous substance in the workplace air. We determine the Occupational Exposure Limits and the resulting safety measures.

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Elemental Impurities

Traces of metal in pharmaceutical product can endanger the safety of patients. To limit the risk of these potentially toxic elemental impurities, we provide you with the required risk assessment and help you to form according risk control strategies.

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Extractable & Leachable Impurities

Materials used in pharmaceutical packaging or in the manufacturing process can pose health risks if they migrate to the finished pharmaceutical product. We assess the risks of materials and and determine which ones are compatible with your product.

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Toxicological Evaluation of Impurities

Unwanted substances without any therapeutic effect can endanger the safety and efficacy of your pharmaceutical product. We perform toxicological evaluations so you can minimize these organic impurities – and thus not only improve the safety of your product but also avoid expensive recalls.

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Environmental Risk Assessments

Pharmaceuticals might also get into the environment after a product is used by a patient. Avoid potential environmental risks – and get the assessment you need to bring your medicinal product to the market.


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Cosmetics

The European market has separate regulations for cosmetic products. We support you to safely register your cosmetics, to assure the safety of staff involved in manufacture, and, if applicable, to get your product labeled as organic or natural according to COSMOS-standard.

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Biocides

Since biocides are designed with the purpose to kill living organisms, they might also pose a risk to humans, animals, and the environment. Bring your biocide to the market while avoiding hazards to health and the environment.

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Cleaning Validation

Properly cleaning the equipment used in manufacture is essential, especially when multiple pharmaceutical products are manufactured in the same facility. We help you to establish reliable cleaning procedures – and prevent your product from being contaminated.

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