“Salus ante omnia”
“Salus ante omnia”
“Salus ante omnia”
Consultancy Unit
Nowadays the identification of Adverse Outcome Pathways (AOP) and the development of Integrated Approaches to Testing and Assessment (IATA) support the concept of Evidence-Based Toxicology to better capture the effects of chemicals, consumer products and the environment on human health.
Consistently with the new safety requirements introduced in many regulations, an expert and deeper knowledge of the applicability domain of in vitro testing approaches is today highly recommended.
In Vitro Consultancy Unit has the mission to provide its Customers with high level in vitro Testing Strategies for Hazard and Risk Assessment, coupled with an independent pharmaco-toxicological expert judgment.
The Consultancy Unit’s deliverables focus on a more accurate, more ethical approach and supports Customers in high level strategies related to regulatory in vitro toxicology for a sustainable classification of chemicals, pesticides, agrochemicals, new secondary raw materials and in the safety assessment of pharmaceuticals, cosmetics and medical devices.
- Biological Evaluation Plan and Design input within a risk management process in accordance with ISO 14971:2007 and Gap analysis to ISO standards.
- MD Raw Materials toxicological characterization and safety assessment according to EN ISO 10993- 1:2018 and following the process of an in-depth literature review as indicated in Annex C.
- Risk assessment on absorption, penetration and local distribution of devices composed of substances or of combinations of substances, that are intended to be introduced into the human body via a body’s orifice or applied to the skin as required by Rule 21 of MDR 2017/745.
- Toxicological expertise on the results of in vitro percutaneous absorption studies (OECD TG 428 and EFSA 2017 guidelines). Assessment of systemic exposure for the identified use and calculation of safety margins.
- Toxicological risk assessment of residual impurities from the manufacturing process (ISO 10993-18), products’ degradation (ISO 10993-13/14/15) and substances extracted and/or released by the primary packaging in the MD (ISO 10993-17) including polymers (plastic/silicon), solvents, elemental and genotoxic impurities and definition of their safety limits.
- Biocompatibility Test Plan strategy development following 3R principles, thus avoiding animal testing using Alternatives, and in silico prediction.
- Interpretation of the results obtained in the biocompatibility and the overall biological safety in accordance with EN ISO 10993-1:2009 and the subsequent amendments.
Consultancy Unit
Nowadays the identification of Adverse Outcome Pathways (AOP) and the development of Integrated Approaches to Testing and Assessment (IATA) support the concept of Evidence-Based Toxicology to better capture the effects of chemicals, consumer products and the environment on human health.
Consistently with the new safety requirements introduced in many regulations, an expert and deeper knowledge of the applicability domain of in vitro testing approaches is today highly recommended.
In Vitro Consultancy Unit has the mission to provide its Customers with high level in vitro Testing Strategies for Hazard and Risk Assessment, coupled with an independent pharmaco-toxicological expert judgment.
The Consultancy Unit’s deliverables focus on a more accurate, more ethical approach and supports Customers in high level strategies related to regulatory in vitro toxicology for a sustainable classification of chemicals, pesticides, agrochemicals, new secondary raw materials and in the safety assessment of pharmaceuticals, cosmetics and medical devices.
CONTACT USContact VitroScreen’s In Vitro Consultancy Unit. Let us help you navigate the evolving regulatory landscape with confidence and ensure the best in vitro testing strategy for your products. |
Contact us |
CONTACT USContact VitroScreen’s In Vitro Consultancy Unit. Let us help you navigate the evolving regulatory landscape with confidence and ensure the best in vitro testing strategy for your products. |
Contact us |
CONTACT USContact VitroScreen’s In Vitro Consultancy Unit. Let us help you navigate the evolving regulatory landscape with confidence and ensure the best in vitro testing strategy for your products. |
| Contact us |
The Consultancy Unit Support
The Consultancy Unit supports the Medical Devices industries facing the MDR 2017/745 requirements.- Biological Evaluation Plan and Design input within a risk management process in accordance with ISO 14971:2007 and Gap analysis to ISO standards.
- MD Raw Materials toxicological characterization and safety assessment according to EN ISO 10993- 1:2018 and following the process of an in-depth literature review as indicated in Annex C.
- Risk assessment on absorption, penetration and local distribution of devices composed of substances or of combinations of substances, that are intended to be introduced into the human body via a body’s orifice or applied to the skin as required by Rule 21 of MDR 2017/745.
- Toxicological expertise on the results of in vitro percutaneous absorption studies (OECD TG 428 and EFSA 2017 guidelines). Assessment of systemic exposure for the identified use and calculation of safety margins.
- Toxicological risk assessment of residual impurities from the manufacturing process (ISO 10993-18), products’ degradation (ISO 10993-13/14/15) and substances extracted and/or released by the primary packaging in the MD (ISO 10993-17) including polymers (plastic/silicon), solvents, elemental and genotoxic impurities and definition of their safety limits.
- Biocompatibility Test Plan strategy development following 3R principles, thus avoiding animal testing using Alternatives, and in silico prediction.
- Interpretation of the results obtained in the biocompatibility and the overall biological safety in accordance with EN ISO 10993-1:2009 and the subsequent amendments.
The Consultancy Unit Support
The Consultancy Unit supports the Medical Devices industries facing the MDR 2017/745 requirements.- Biological Evaluation Plan and Design input within a risk management process in accordance with ISO 14971:2007 and Gap analysis to ISO standards.
- MD Raw Materials toxicological characterization and safety assessment according to EN ISO 10993- 1:2018 and following the process of an in-depth literature review as indicated in Annex C.
- Risk assessment on absorption, penetration and local distribution of devices composed of substances or of combinations of substances, that are intended to be introduced into the human body via a body’s orifice or applied to the skin as required by Rule 21 of MDR 2017/745.
- Toxicological expertise on the results of in vitro percutaneous absorption studies (OECD TG 428 and EFSA 2017 guidelines). Assessment of systemic exposure for the identified use and calculation of safety margins.
- Toxicological risk assessment of residual impurities from the manufacturing process (ISO 10993-18), products’ degradation (ISO 10993-13/14/15) and substances extracted and/or released by the primary packaging in the MD (ISO 10993-17) including polymers (plastic/silicon), solvents, elemental and genotoxic impurities and definition of their safety limits.
- Biocompatibility Test Plan strategy development following 3R principles, thus avoiding animal testing using Alternatives, and in silico prediction.
- Interpretation of the results obtained in the biocompatibility and the overall biological safety in accordance with EN ISO 10993-1:2009 and the subsequent amendments.
VitroScreen & ToxHub: a Powerful Partnership for Product Safety and Regulatory Compliance
Combined Expertise, Unmatched Solutions:
This collaboration brings together VitroScreen’s renowned experience in providing the best in vitro testing strategy with ToxHub’s profound knowledge of toxicological and regulatory challenges.VitroScreen & ToxHub: a Powerful Partnership for Product Safety and Regulatory Compliance
Combined Expertise, Unmatched Solutions:
This collaboration brings together VitroScreen’s renowned experience in providing the best in vitro testing strategy with ToxHub’s profound knowledge of toxicological and regulatory challenges.Our combined expertise delivers:
- Comprehensive solutions: Address complex issues across product development, toxicology,
and regulatory aspects. - Scientific and regulatory synergy: Combine scientific depth with regulatory insights
for optimal outcomes. - Tailored and cost-effective solutions: Benefit from customized approaches suited to
your specific needs.
In addition to these services, ToxHub provides efficacy assessments thanks to a team of
experienced pharmacologists. This means that not only can ToxHub help you ensure the safety
of your product, but they can also help you demonstrate that it works as intended.
Independence and transparency in toxicological assessments are keys factor.
As an independent consultancy company, ToxHub assures you of:
- Objective and unbiased evaluations
- Reliable data analysis
- Confidence in regulatory compliance
The In Vitro Consultancy Unit supports Customers in:
- establishing the toxicological profile of ingredients
- providing an independent toxicological expert judgment (ERT toxicologist) on available data
- performing a gap analysis
- identifying the most appropriate and sustainable experimental in Vitro approach according to product type, chemical-physical properties and product category
Our combined expertise delivers:
- Comprehensive solutions: Address complex issues across product development, toxicology,
and regulatory aspects. - Scientific and regulatory synergy: Combine scientific depth with regulatory insights
for optimal outcomes. - Tailored and cost-effective solutions: Benefit from customized approaches suited to
your specific needs.
In addition to these services, ToxHub provides efficacy assessments thanks to a team of
experienced pharmacologists. This means that not only can ToxHub help you ensure the safety
of your product, but they can also help you demonstrate that it works as intended.
Independence and transparency in toxicological assessments are keys factor.
As an independent consultancy company, ToxHub assures you of:
- Objective and unbiased evaluations
- Reliable data analysis
- Confidence in regulatory compliance
The In Vitro Consultancy Unit supports Customers in:
- establishing the toxicological profile of ingredients
- providing an independent toxicological expert judgment (ERT toxicologist) on available data
- performing a gap analysis
- identifying the most appropriate and sustainable experimental in Vitro approach according to product type, chemical-physical properties and product category
