Reports

Safe Product Development with Expert Reports

Meet our toxicology consulting service driven by scientific accuracy, regulatory compliance, and commitment to human health. We provide toxicological assessment reports compliant with national and international regulations for pharmaceutical, cosmetic, biocidal, medical device, and environmental products. Our expert team helps document your product safety with comprehensive services such as PDE (Permitted Daily Exposure) calculations, ecotoxicological risk analyses, and clinical and nonclinical toxicity evaluations, all in line with guidelines from authorities like EMA, FDA, and EPA.
Additionally, we accelerate your process by providing technical documentation support in CTD format for licensing dossiers related to pharmaceuticals, cosmetics, and medical devices. We contribute to the safe and swift market entry of your products by offering toxicological risk assessments across a wide range, from food and feed products to disinfectants. Each of our reports supports your decision-making with scientifically grounded, expert-opinion-based results.
Because we don’t just deliver reports—we build trust at the intersection of health and science.

When different medical products are manufactured in shared facilities, the potential for cross-contamination is a source of concern. Medical products provide benefits to the intended patient or target animal; however, cross-contaminants offer no benefit to the patient or target animal and may even pose risks. Therefore, the presence of such contaminants must be managed based on the risk related to levels considered safe for all populations. To address this, health-based limits should be established by deriving a safe threshold value to identify emerging risks. The derivation of such a threshold value (e.g., Permitted Daily Exposure (PDE) or Toxicological Concern Threshold (TTC)) should result from a structured scientific evaluation of all available pharmacological and toxicological data, including both nonclinical and clinical data. Deviations from the main approach emphasized in this guideline for obtaining such safe threshold levels may be acceptable if adequately justified. The Permitted Daily Exposure (PDE) is derived based on comprehensive existing nonclinical and clinical data and represents a dose to which an individual can be exposed daily by any route throughout their lifetime without likely adverse effects. These reports are prepared according to the European Medicines Agency (EMA) guidelines for pharmaceutical, supplement, herbal product, cosmetic, and personal care companies to assess cross-contamination risks.

Ecotoxicological risk assessment reports evaluate the hazard potential of existing or new environmental chemicals to the ecosystem. In this context, two questions must be answered: What are the environmental concentrations, and what are the expected effects? These reports are prepared to assess the environmental risk of specific substances according to the guidelines of the European Medicines Agency (EMA) and the Environmental Protection Agency (EPA) for pharmaceuticals, supplements, herbal products, cosmetics, personal care companies, and biocidal products.

These reports evaluate the clinical aspects of new or generic drugs. All clinical data for each drug molecule in a formulation are included. They are prepared for pharmaceutical companies according to the guidelines of the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) to assess the risk of drug use in both sensitive and general populations. An expert opinion is added at the end of the report for an overall assessment of clinical toxicological risks.

These reports evaluate the clinical aspects of new or generic drugs. All clinical data for each drug molecule in a formulation are included. They are prepared for pharmaceutical companies according to the guidelines of the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) to assess the risk of drug use in both sensitive and general populations. An expert opinion is added at the end of the report for an overall assessment of clinical toxicological risks.

These reports evaluate the clinical aspects of new or generic drugs. All clinical data for each drug molecule in a formulation are included. They are prepared for pharmaceutical companies according to the guidelines of the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) to assess the risk of drug use in both sensitive and general populations. An expert opinion is added at the end of the report for an overall assessment of clinical toxicological risks.

These reports include all available toxicological data for a cosmetic or personal care product. Systemic exposure dose (SED) calculations are performed using no observed adverse effect levels (NOAELs) of the ingredients. An expert opinion is added at the end of the report for an overall assessment of toxicological risks.

These reports include all available toxicological data for a specific drug molecule or other drug components. Safety calculations for the use of drugs are performed for a specific drug formulation. An expert opinion is added at the end of the report for an overall assessment of toxicological risks.

The idea of compiling all quality, safety, and efficacy information into a common format called the Common Technical Document (CTD) revolutionized regulatory review processes and enabled compatible electronic submissions. Therefore, CTDs ensure the implementation of good review practices. For different industries, CTDs eliminate the need to reformat information for submission to various ICH regulatory authorities. The CTD is organized into five modules. Module 1 is region-specific, while Modules 2, 3, 4, and 5 are intended to be common across all regions. CTD has become a mandatory format for new drug applications in the EU and Japan and is recommended by the FDA in the United States. In some countries, CTDs are also required or recommended for medical devices and cosmetics.

Marketing authorization dossiers for pharmaceuticals are prepared according to the format requested by regulatory authorities. The dossiers may consist of different modules depending on the country, and the pharmaceutical company seeking registration for a specific drug molecule must provide our company with the registration dossier format.

Marketing authorization dossiers for pharmaceuticals are prepared according to the format requested by regulatory authorities. The dossiers may consist of different modules depending on the country, and the pharmaceutical company seeking registration for a specific drug molecule must provide our company with the registration dossier format.

Marketing authorization dossiers for pharmaceuticals are prepared according to the format requested by regulatory authorities. The dossiers may consist of different modules depending on the country, and the pharmaceutical company seeking registration for a specific drug molecule must provide our company with the registration dossier format.

Marketing authorization dossiers for pharmaceuticals are prepared according to the format requested by regulatory authorities. The dossiers may consist of different modules depending on the country, and the pharmaceutical company seeking registration for a specific drug molecule must provide our company with the registration dossier format.

Chemical risk assessment in food and feed safety involves a wide range of disciplines and research areas such as chemistry, biology, toxicology, epidemiology, biostatistics, and modeling. The aim of chemical risk assessment is to measure chemical exposures (exposure assessment) from specific sources and routes (inhalation, oral, dermal, water/food, skin) for a given population or species; to determine safe levels for chemicals (hazard identification and characterization); and to quantify the risk associated with such exposures (risk characterization). These reports include all toxicological data for food or feed ingredients and perform specific calculations using acceptable daily intake (ADI) or upper limits (ULs). An expert opinion is added at the end of the report for an overall assessment of the toxicological risks of food or feed ingredients.

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