Over the last 20 years, we have worked with a huge number of academic labs, start-ups, small- and mid-size pharmaceutical and chemical companies, venture capital organizations and other investors, but prefer not to disclose the names of our clients. Please contact us for detailed information on our experience with specific classes of drugs or areas of indication.
Toxicologic pathology of GLP rodent and non-rodent toxicity studies
We frequently read slides from regulatory toxicity studies of all species (mice, rats, hamsters, dogs, minipigs, monkeys) and conduct a thorough evaluation of macroscopical and microscopical observations. We are able to conduct this under GLP conditions and document all findings in the PROVANTIS system (Instem).
Preclinical strategy for newly formulated drugs with reference to marketed drugs
We have assisted many projects in which marketed active pharmaceutical ingredients are developed for use in different formulations and/or indications. We have thoroughly evaluated the available preclinical data and have generated strategies to bridge to the new product in support of US FDA 505b(2) applications and EU hybrid or mixed applications.
Regulatory dossiers for new and existing medicinal products
We have generated a large number of regulatory dossiers (CTD pharmacology, pharmacokinetics and toxicology modules) for new small molecules and biotechnology-derived products. We have also generated nonclinical overviews (CTD module 2.4) for marketed drugs, which needed update or revision. We also review regulatory dossiers written by our clients to identify any potential gaps in preparation for submission.
Expert advice on the pharmacological profiling of new drug candidates
We have assisted many customers in contracting in vitro and in vivo pharmacology studies to evaluate the pharmacological properties of new drug candidates. This includes a broad range of indications, including oncology and autoimmune diseases.
Pathology peer Reviews of GLP toxicity studies
We regularly conduct pathology peer reviews of GLP toxicity studies or participate in pathology working groups. We can conduct the peer reviews at any CRO in the world, or have the slides sent to our GLP facility. We also conduct expert reviews on digitalized slides (whole slide images).
Pathology expert reports
We evaluate pathology data and integrate it with clinical pathology data and clinical observations, in order to assist in data interpretation. We also assist in developing strategies to investigate mechanisms of toxicity employing immunohistochemistry or molecular pathology techniques.
Preclinical development training
We provide customized training in preclinical drug development, according to the specific requirements of our customers. Training is usually provided in the form of seminars including lots of case examples and interactive exercises.
Set-up of a toxicological qualification process for leachables and extractables
Together with A&M Stabtest we developed a tiered approach for the qualification of L & E based on the measured concentrations of the compounds and the resulting maximum daily intake. We use Thresholds of Toxicological Concern (TTC), quantitative structure-activity-relation (QSAR), literature data and experimental data (in vitro and in vivo) to qualify the respective compounds.
Toxicological assessments of plant extracts intended in drug and food supplement entities
In contrast to defined drug molecules or industrial used chemicals, plant extracts encompass often a multitude of compounds and therefore different strategies have to be applied to assess the safety of the product. Additionally to standard methods, these include structural grouping, in silico QSAR approaches, assessment of lead structures and comparison to reference values from food intake.