Human Medicinal Products

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Human medicinal product is defined as a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action in humans (EMA).

Medicines can only be placed on the marked after they have been authorised, which means, that they must undergo strict testing and an assessment of their quality, safety and efficacy. The relevant provisions are primarily laid down in Directive 2001/83/EC and Regulation (EC) No 726/2004. Depending on the type of medicine, a marketing authorisation, a certificate of registration or a certificate of traditional-use registration must be obtained. Granting of the authorisation or certificate is proof that the medicine complies with the required standards.

Human medicinal products are assessed using three criteria:

  • quality - e.g. manufacturing methods and dosage form, composition, analysis, quality control, stability and shelf life etc.
  • efficacy - the ability of a drug to produce a maximum response. It is an inherent property of an agonist that determines its ability to produce its biological effect. It is a property of the drug, not the receptor or tissue
  • safety - relates to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products

The safety of drugs is related to the potential for adverse drug-related effects and is requisite to conduct for Pharma & Biotech sector prior marketing.  Efforts to establish a safe profile of medicinal products begin with development of in vitro and in vivo toxicity testing at the initiation of their development and continue with clinical trials leading up to drug approval in specific post-marketing studies or in general pharmacovigilance efforts.

Comprehensive preclinical safety testing in vitro and in animal models is mandatory when developing a potential new pharmaceutical compound. Safety data usually comprise a package of toxicology data that is primarily used to assess user safety.

A special part represents an environmental risk assessment (ERA) of Human Medicinal Products for purposes of European Medicines Agency (EMA) acc. to EMEA/CHMP/SWP/4447/00 Rev. 1, which comprise of two phase with determination of physico-chemical properties, environmental fate and toxicity of active substances. 

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InterBioTox has a huge potential to support the clients in safety and efficacy drug testing acc. to ICH guidelines, incl. determination of Genotoxic Impurities of Pharmaceuticals. The further services of InterBioTox are  different laboratory tests for environmental development and performance of ERA.

Toxicology Consulting

Our long-standing experts provide a valuable toxicology consultancy for pharmaceutical, medical device and biotechnology products, incl. Toxicological Risk Assessments (TRA), Scientific and medical writing services, Establishing Health-Based Exposure Limits and Extractables and Leachables Studies. Choose the study...

Analytical Chemistry

InterBioTox offers a complete GLP and GMP analytical services for determination of your human medicinal product during preclinical development, in order to achieve product safety and regulatory compliance, and maintain the highest levels of laboratory quality control. The laboratories perform method development  and analytical validation of the medicinal products / active substances in many matrices. Choose the study...


InterBioTox offers the aquatic and sediment ecotoxicology studies incl. Activated Sludge, Respiration Inhibition Test to support ERA (Environmental Risk assessment, Phase II, acc. to EMEA/CHMP/SWP/4447/00) on medicinal products substances for your environmental safety assessment, fully  in compliance with principles of GLP. Choose the study...


The selected OECD 301 biodegradation studies are recommended for Environmental Risk assessment Phase II acc. to EMEA/CHMP/SWP/4447/00. Laboratories of InterBioTox can help you to suggest the right strategy in GLP to evaluate a potential biodegradation and persistency of your human medicinal product. Choose the study...

Physico-chemical properties

InterBioTox provides physico – chemical studies (e.g. water solubility, partition coefficient etc.) for compliance with Environmental Risk assessment, Phase II ac. To EMEA/CHMP/SWP/4447/00. Choose the study...

Environmental Fate

In the same way like biodegradation studies, InterBioTox offers a selected environmental fate studies (e.g. OECD 106 Adsorption/Desorption) to be complied with Environmental Risk assessment, Phase II acc. to EMEA/CHMP/SWP/4447/00. Choose the study...

In vitro Toxicology

Where it is allowed, InterBioTox provides a replacement of in vivo testing with in vitro toxicology studies in GLP quality as an suitable alternative for in vivo nonclinical safety assessment. Typical in vitro studies are in vitro genotox studies within Genotoxic Impurities of Pharmaceuticals (ICH Q3A), resp. nonclinical safety studies acc. to ICH M3 (R2), and for topically applied or exposed human medicinal products, within an assessment of the skin corrosion and irritation potential, through in vitro skin validated models, as a key element in their safety evaluations (ICH M3 (R2)). Choose the study...

In vivo Toxicology

Nonclinical (or preclinical) toxicology studies are required to establish the toxicological profiles of new drug candidates prior to administration to humans, and to extend the known profiles of existing drugs (e.g., new indications, new formulations, new routes of administration, etc.). Some nonclinical studies may be conducted in a non-GLP regime for preliminary investigations; however, it is expected that studies used for direct extrapolation to human safety will be conducted according to GLP.  InterBioTox performs a comprehensive mammalian / in vivo toxicology for your drugs to be performed as acute, sub-chronic, chronic and reproductive & developmental toxicology studies, genotox studies, local tolerance studies in GLP regime for purposes of the nonclinical safety evaluation acc. to requirements of ICH M3 (R2). A special part represents pharmacodynamic studies. Choose the study...


Histopathology, as a requisite part of the in vivo toxicology studies is performed by the laboratory of InterBioTox to support an evaluation of human medicinal products with respect to impacts to human health and nonclinical safety evaluation. Choose the study...


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