Innoqua Toxicology Consultants, S.L. (Innoqua) is a consultancy organization based in Barcelona and Madrid (Spain). Founded in 2004, Innoqua is made up of a team of professionals with significant combined experience in toxicology, safety assessment, regulatory framework and project management skills. Innoqua provides assistance to third party companies in a wide range of activities related with preclinical development.
An increasing number of companies in Pharmaceutical and Biotechnology industries put their drug substances and products into our hands to deal with the nonclinical development from selection of drug candidate through to clinical phase approval in Europe and US. Innoqua helps with the design of tailored nonclinical programs, interpretation of toxicological issues, preparation of regulatory dossiers, regulatory scientific advice procedures, direct management and monitoring of toxicology studies, and assessment on critical safety issues of the drug products.
Our experience is backed up by our direct involvement in more than 500 nonclinical studies, 40 nonclinical programs of new chemical entities as well as drug repositioning. Among them, 16 projects are already in clinical phases I and II in Europe and the US, and have reached satisfactory full compliance from EMA, FDA and local agencies. We have experience in many routes of administration including oral, dermal, intravenous infusion and inhalation; and therapeutic areas such as cancer, diabetes and metabolic diseases, Parkinson’s disease and other neurodegenerative diseases, pain, hypertension, immunomodulators, vaccines, orphan diseases, etc.
Innoqua also provides assistance in the safety assessment and execution of toxicological studies required for Medical devices to be placed on the market. Likewise, our experts help our clients to assess the safety of new Cosmetic ingredients and products, being certified to make safety assessment reports in accordance with the new European Cosmetics regulation requirements.
INNOQUA can also offer safety evaluation and monitoring of toxicological studies on veterinary medicines, agro-chemical products and food additives in accordance with their respective regulations.
We naturally make sure that all the nonclinical safety studies performed for our customers are fully compliant with the Good Laboratory Practice regulations (GLP) as required.
We invite you to look further into our services to find out how our expertise, commitment and flexibility can contribute to make safer drugs and chemicals and help your company to simplify the long process to assess the safety of your products and meet regulatory milestones in a timely, smooth and cost-efficient way.
Eduardo Cunchillos, Founder and Managing Director
Ana Andrés Perni
Juan Román Jiménez
For more details about our team, please check this link
Pharmaceutical & Biotech Industry
We prepare nonclinical programs tailored to the specific needs of your compounds under development. We understand that every test substance has unique pharmacological properties and toxic class alerts and is under scope of different regulatory framework with regards to its chemical nature, origin or clinical indication.
Strategic and financial circumstances of each sponsor are also unique. It is for all this, we think that every nonclinical program is different and needs to be adjusted to particular situations.
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Medical Devices
Categorization of medical devices to select the appropriate nonclinical tests to perform, taking into account the type, degree and duration of contact of the medical device with the body, as well as the toxicological profile of the substances present in the final product and the amount of such substances that can be available to the human body.
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Cosmetics
We support our client on the safety assessment of cosmetic products in accordance with the requirements of the cosmetic directive and regulation in force.
The safety assessment will be based on available peer-reviewed toxicology literature, MSDSs, trade association documents, and governmental listings and databases. In case that not sufficient information is available from these sources, and if experimental evidence is required, we would place studies, and monitor CROs capable of carrying out in vitro toxicology studies in accordance with appropriate guidelines.
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Veterinary Medicinal Products
We prepare nonclinical programs tailored to the specific needs of your pharmaceutical and immunological veterinary products under development. We understand that every test substance has unique pharmacological properties and toxic class alerts and is under scope of different regulatory framework with regards to its chemical nature, origin or clinical indication.
Strategic and financial circumstances of each sponsor are also unique.
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Agrochemicals & Food Additives
We offer support for meeting REACH regulation from a technical and toxicological perspective evaluating the available information and/or defining the toxicological studies claimed for this regulation.
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GLP: Good Laboratory Practices
Acting as monitoring scientist we verify the GLP compliance of the main documents in a GLP study such as protocol and final report according to OECD (ENV/MC/CHEM(98)17) and FDA (21 CFR 58) standard. We could also provide support on the process and facility inspections as well as on raw data and SOP verification in the studies we are involved in.
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Our list of customers has been continuously growing since we started our consultancy activity and, most importantly, we regard our customer’s satisfaction as our best credential. They have entrusted their projects to us for several years and will certainly do it again.
The key of this satisfactory relationship is based on the philosophy that inspires our work:
Independency to advise our customers on the best strategies for their interests
Personal commitment to feel their projects as ours, putting effort and interest into the progress of the project, and meeting timelines as if we were integrated in their research team.
Honesty to recommend the most straightforward path and to avoid conducting unnecessary tasks and thus, optimizing costs.
Balance between our customer’s interests and fulfilment of regulatory requirements, always ensuring that the safeguard of public health is our mutual goal.
Flexibility to adjust our scope of collaboration and rhythm to our customer’s needs.
In addition, confidentiality, experience, plus scientific and regulatory background are prerequisites without which we cannot satisfactorily do our job.
Summing up, we are committed to help our customers to simplify the long process to assess the safety of their products and to meet regulatory milestones in a smooth, timely and cost-effective way.
Innoqua provides assistance to third party companies in the pharmaceutical and biotechnology sectors in a wide range of activities related to pre-clinical development.
