Medicines are regulated by governmental agencies (in Europe, it is EMA) and is necessary a strict compliance with the requirements for their authorization. We can advise on the compliance of these requirements. Among other we do the following studies:
Report of mutagenic impurities:
Determination of the PDE value of Active Ingredients:
Evaluation of the presence of nitrosamines in medicines:
The interaction of the chemical substances with people is given through food and its containers (Food Contact Materials), drinking water, cosmetic products and air. The safety of this relationship can be determined by knowing the toxicity of the substance we want to study, for example evaluate if the substance is skin sensitizing and can be used as an ingredient in a cosmetic product or if it is necessary to protect the worker during handling. For many substances it is known what their safe daily intake is (ADI), having this information or doing an estimation from similar substances it is necessary when you want to use this substance as an ingredient in a product for the human consumption. We offer you to evaluate the existing information and make predictions with computational methods for products that are of interest to you.
Workers’ exposure to chemicals should be limited below a limit (called Occupational Exposure Limit, OEL) to avoid any adverse effect on the health of workers. This limit is established for some substances (GESTIS DNEL List) but there are many in which they have no value. It is therefore necessary to determine the OEL for many substances in which it is not known how the worker can be protected. We offer you to prepare a report that determines the OEL value of the required chemical substance.
Medicine to treat animals have some regulations that are similar to the regulations of medicines for human use: Mutagenic impurities are limited with a guide very similar to the ICH M7:
Current legislation protects the use of animals in medicine development and authorization processes for people and animals. This regulation is based on the principle of the three R (3Rs, Replacement, Reduction and Refinement) which reduces experiments with live animals to a minimum. Within this approach to chemical products safety (whether or not they are medicines) computational methods are of great importance (SAR, QSAR and Read-Across) because they allow us to know the toxicity of a substance with a reliability very close to that obtained with animal experimentation. We can study the products of your interest form this perspective, please contact us.
New or existing medicines when they are placed on the market require an environmental assessment for their authorization (Environmental Risk Assessment). In the same way, for any chemical product it is necessary to know its environmental impact (see REACH legislation) and include this information in its Safety Data Sheet. We can provide new information to its Safety Data Sheets on the toxicity and physicochemical properties of your products.
Natural and synthetic products
To know if a certain substance is either natural or cannot negatively affect people, animals or environment, we have to know which are some of its physicochemical properties (solubility in water, octanol/water partition coefficient, steam pressure, fusion point, etc.). Sometimes there is information about these properties, but this is not always the case, when this happens computational methods are the most valid alternative (QSPR). The best solution is to always use all available programs and evaluate the data obtained with Weight of Evidence procedure.
The toxicity of the studied substance is obtained from the published experimental information, but if this information does not exist, it can be obtained from predictions made with different computational methods. We offer you these studies that are aimed at completing the product Safety (safety data sheet) Data Sheet we are considering. Within this section we also offer you studies related to the development and validation of methods of analysis of any substance in different matrices.