SOLUTIONS | innvitro

SOLUTIONS BY BUSINESS SEGMENT

GROUP 1

QUALITY ASSURANCE

STUDY MANAGEMENT

QUALITY MANAGEMENT ALLIED WITH SCIENTIFIC KNOWLEDGE

With hundreds of projects executed, our team specialized in all areas involved in quality management can implement from biological testing to quality management systems, helping to ensure the validity of the results generated:

Training and planning for implementation of toxicology testing;
Planning and support for the implementation of quality management systems ISO/IEC 17025:2015 and GLP;
Internal evaluations of the ISO/IEC 17025:2015 and GLP quality management system;
In-company training of the team in management systems;

We guide you in meeting the standards.

ABNT NBR ISO/IEC 17025:2015, NIT-DICLA 35 and complementary standards, OECD Guidelines.

Contact our team right now and find out the best way to adjust your processes. We are here to resolve.

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GROUP 2

PHARMACEUTICAL DRUGS

MEDICAL DEVICES

FOODS

COSMETICS

TOXICOLOGY APPLIED TO THE SAFETY OF PRODUCTS FOR HUMAN USE

Discover our unique approach, built on years of hands-on experience, to help you from initial development to registration and post-registration. We have specialized in helping your company guarantee the safety of your product at different stages of the process:

Design and management of projects for the screening of new substances/products
Evaluation of the safety and efficacy based on a review of technical and scientific literature
Experimental design and management of non-clinical safety and efficacy trials
Establishment of Health-Based Exposure Limits (HBEL; PDE)
Qualification of degradation products and impurities
Nitrosamine evaluation
Biocompatibility assessment
Toxicological evaluation
In-company team training
New Methodological Approaches (NAMs) to the use of animals
In silico toxicology assessment

We guide you in meeting the regulations.

Pharmaceutical Drugs: ANVISA RDC 658/2022, ANVISA RDC 53/2015, ANVISA RDC 494/2021, ANVISA RDC 500/2021, ANVISA Non-clinical trials guide, ANVISA RDC35/2015

Medical Devices: ANVISA RDC56/2001, ISO 10993

Food: RDC 243/2018, ANVISA Guide 23/2019, RDC 241/2018

Cosmetics: RDC7/2015, RDC 288/2019, RDC35/2015

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VETERINARY DRUGS

AGROCHEMICALS

SANITIZING PRODUCTS

TOXICOLOGY APPLIED TO THE PROTECTION OF HUMAN, ANIMAL, AND ENVIRONMENTAL HEALTH

With years of experience and a highly specialized team, we help from initial development to regulatory requirements. With hundreds of completed projects, we help your company ensure the safety of your product at different stages:

Toxicological evaluation based on a review of technical and scientific literature;
Experimental design and management of non-clinical safety trials;
Toxicological classification;
Establishment of health-based limits (IDA, AOEL);
Toxicological risk analysis;
Analysis of environmental hazards;
Ecotoxicological risk analysis;
Alternative methodologies to animal use;
In-company training of the team;
New Methodological Approaches (NAMs) to the use of animals.

We guide you in meeting ANVISA and IBAMA's standards

Agrochemicals: Decree 10.883/2021, ANVISA RDC 294/2019, ANVISA RDC 295/2019, ANVISA CP987/2020, ANVISA RDC35/2015, IBAMA Normative 84/1996, IBAMA IN 27/2018, IBAMA PPA 2019.

Sanitizing Products: Decree No. 4.074/2002, INC No. 03/2006, ANVISA IN 04/2013, ANVISA IN 12/2016, ANVISA RDC 34/2010, ANVISA RDC 59/2010, ANVISA RDC 34/2010

Veterinary Drugs: Law 14.187: 2021, ANVISA RDC 328/2019

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GROUP 3