Design of Nonclinical Development Programs

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 falls under the scope of different regulatory frameworks with regards to its chemical nature, origin or clinical indication.
Strategic and financial circumstances are also unique for each client.

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We therefore recognise that every nonclinical program needs to be adjusted to particular situations. Our aim is to provide tailored programs that in first instance fulfil EMA and FDA requirements according to ICH and local guidelines and secondly, avoid conducting unnecessary studies and therefore optimizing costs.

We give special attention to designing programs adjusted for biologic, biotech-derived or repositioning products.

We also review your existing nonclinical programs and advise you on potential refining if needed.

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Management and Monitoring of Nonclinical Studies

The management and monitoring activities that we usually provide to our customers include involvement on study design,  selection of suitable CROs around the world (considering expertise, slots and prices),  requests for cost estimates to CROs,  definition and critical review of protocol to ensure regulatory compliance, management tasks, direct communication with study directors, follow-up / monitoring of all study activities, coordination of tasks in multisite studies, assistance on any decisions along the study and critical review of the study report.

Interpretation and Assessment on Nonclinical Safety Data
We help clients to identify critical issues with regards to safety, and assess the relevance of data, the impact on viability of the project and provide advice on follow-up studies.
Preparation of Technical and Regulatory Documents
We prepare safety assessment reports, expert reports  and the nonclinical sections of Investigators Brochure, IMPD, IND and CTD according to Notice to Applicants recommendations, as well as Nonclinical Overviews based on the client’s own studies or bibliography (generic drugs).
Preparation of Scientific Advice Requests to Agencies
We provide assistance to pharma/biotech companies in the preparation of Scientific Advice requests to EMA, FDA or local agencies, identifying critical issues in the nonclinical  development plan that require regulatory feedback and constructing the rationale for the company’s position.
Selection and Inspection of CROs

We manage nonclinical studies around the world. We are happy placing the studies in the CROs of the sponsor’s preference. For those studies that require specific expertise we advise our customers on the most experienced CROs in the area, or on the best balanced CROs on a quality/price based ratio.

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We can perform on-site CRO inspection on behalf of the sponsor with different objectives that include suitability of the CRO to conduct the studies required by our customer, monitoring of ongoing studies, verification of GLP compliance in customer studies, and technical meetings with scientific staff.

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Impurities and Excipients Qualification

We deal with the qualification of impurities of either new active substances or new products, (including generic drugs) according to ICH Q3A and Q3B. The qualification will be based on bibliography whenever possible, or by testing the impurity in the required toxicological assays. We assess the genotoxic potential of impurities according to the recent ICH M7 guideline using QSAR analysis and/or genotoxicity tests.

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We prepare impurity qualification reports or help our customers provide the adequate information to the agencies requiring clarifications.

Similarly, we assist our customers on the studies required and best strategy to qualify new excipients.

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Determination of Permitted Daily Exposure (PDE)
[En Español]

Determination of Permitted Daily Exposure (PDE) to establish safe exposure limits in manufacturing shared facilities: The EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012) regulates the need to establish limits for contamination of residual active substances in multiproduct manufacturing plants.

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Such limits have to be considered for the validation of cleaning process and have to be based on toxicological and pharmacological properties of each active substance in order to ensure that potential contamination cannot result in any safety concern.

The exposure limits regulatory accepted for most substances are the Permitted Daily Exposure (PDE) and the Threshold of Toxicological Concern (TTC). The guideline establishes that the most appropriate limit value has to be calculated after expert assessment of the toxicological and pharmacological available information.

Innoqua Toxicology Consultants prepares reports of PDE determination for each active substance. The reports are signed by our certified toxicologists and accompanied by their curriculum vitae to fulfill with the guideline requirements.

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[In English]

Cálculo de PDE (Permitted Daily Exposure) para establecer límites seguros de exposición en instalaciones de fabricación compartida: La guía de la EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” (EMA/CHMP/ CVMP/ SWP/169430/2012) regula la necesidad de establecer límites de contaminación residual de sustancias activas en las instalaciones de fabricación compartida, con el fin de armonizar criterios para los procesos de limpieza.

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Los límites deben estar basados en datos toxicológicos y farmacológicos y deben adaptarse caso por caso para garantizar que la potencial contaminación nunca llegue a suponer un riesgo para la salud del paciente.

Los límites de exposición regulatoriamente aceptados son el Permitted Daily Exposure (PDE) y el Threshold of Toxicological Concern (TTC). La guía establece que el límite de exposición más apropiado debe estar bien argumentado y ser el resultado de la evaluación de la información toxicológica y farmacológica disponible por parte de un experto.

Innoqua Toxicology Consultants elabora informes de determinación del valor PDE para cada substancia activa. Los informes son firmados por nuestros toxicólogos acreditados internacionalmente y van acompañados de su curriculum vitae a fin de cumplir con los requisitos de la Guía.

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Environmental Risk Assement (ERA)
EMA and FDA applicable guidelines define the main requirements for the environmental risk assessment (ERA) of pharmaceuticals and veterinary products. An ERA is required for all new marketing authorisation applications for a medicinal product. We can manage and monitor the whole studies package included in the ERA. We define taloired programs in a case-by case approach.

We prepare the ERA reports summarizing the findings of the studies, calculating the key parameters defined by guidelines and making the necessary assessment of the impact of the drug on the environment. We also prepare ERA reports of generic drugs based on available literature. We have written ERA reports that have been submitted to North American, European and Japanese regularory autorities.
Due Diligence

Innoqua can provide technical support during Due Diligence to identify critical issues, prepare and give adequate responses, and interpret data for either licensing in or licensing out purposes.

Education / Training
We prepare education and tailored training programs related with different areas of nonclinical development of pharmaceutical products.