reprotox

Reproductive Toxicology: Ensuring Safety in Pharmaceuticals and Chemicals

Reproductive toxicology (Reprotox) is a critical aspect of product development in the pharmaceutical and chemical industries. It involves the study of substances that affect the reproductive system and may cause disorders such as infertility, developmental issues, and birth defects. At Vivotecnia, we offer comprehensive reproductive toxicology services to ensure the safety and efficacy of your products, both for pharmaceutical and chemical applications.

Understanding Reproductive Toxicology

Where there are no concerns over reproduction or development, REACH calls for starting with the screening study (OECD421/422) at this tonnage.

Where there are serious concerns about the potential for adverse effects on fertility or development, either a prenatal developmental toxicity study or a two-generation or extended one-generation reproductive toxicity study may be proposed instead of the screening study.

Our Services in Reproductive Toxicology

At Vivotecnia, we offer a comprehensive suite of reproductive toxicology services, tailored to meet the unique needs of both pharmaceutical and chemical product development. Our services include:

        1.  Screening Studies (OECD421/422): These are the initial studies conducted when there are no serious concerns over reproduction or development. They provide a broad overview of the potential reproductive and developmental effects of a product.
        2. Prenatal Developmental Toxicity Studies: These studies are conducted to assess the potential adverse effects of a product on the development of the offspring during the prenatal period. They are required for products marketed at 100 TPA and above.
        3. Two-Generation Reproductive Toxicity Studies: These studies are conducted to assess the potential adverse effects of a product on both the parent generation and the offspring. They are typically required when there are serious concerns about the potential for adverse effects on fertility or development, or when the 28-day or 90-day study indicates adverse effects on reproductive organs or tissues.
        4. Extended One-Generation Reproductive Toxicity Studies: These studies are an alternative to two-generation studies and are designed to provide information on the effects of a product on the parent generation and at least one generation of offspring.
        5. In Vivo Mammalian Studies: These studies are conducted to assess the potential adverse effects of a product on mammals. They provide valuable information on the potential risks to humans.

Why Choose Vivotecnia for Reproductive Toxicology Testing?

At Vivotecnia, we are committed to providing high-quality, reliable, and efficient reproductive toxicology testing services. Our team of experienced scientists and techniciansis equipped with the knowledge and skills to conduct comprehensive and accurate reproductive toxicology studies. We adhere to the highest standards of scientific integrity and regulatory compliance, ensuring that our testing services meet the needs of our clients and the expectations of regulatory authorities.
Our state-of-the-art facilities are equipped with the latest technology and equipment, enabling us to conduct a wide range of reproductive toxicology studies. We also maintain a historical control database to ensure the accuracy and reproducibility of our test results.
We understand the importance of timely and efficient testing in the product development process. That’s why we offer flexible scheduling and fast turnaround times, without compromising the quality of our services.

Contact Us Today

At Vivotecnia, we are dedicated to helping our clients ensure the safety and efficacy of their products. If you need comprehensive and reliable reproductive toxicology testing services, contact us today. Our team of experts is ready to assist you with your testing needs.
Ready to ensure the safety and efficacy of your products with comprehensive reproductive toxicology testing? Contact us today to learn more about our services and how we can assist you. Fill out our contact form, and one of our representatives will get back to you as soon as possible.
Remember, at Vivotecnia, your product’s safety is our priority. Let us help you make the world a safer place.

Help, question Icon     Frequently Asked Questions about Reproductive Toxicology Services

    CONTACT

    For more information or a formal quotation, please send us a message and we will contact you as soon as possible.


    You may be also interested in…

    PK/PD and Metabolism

    During the drug discovery process, ADME (absorption, distribution, metabolism, and excretion) and PK studies are deemed necessary to evaluate bioavailability.

    inhalation services

    Inhalation

    Inhalation toxicity studies are required to assess the exposure hazards of consumer products or to manufacturing workers.

     

    General Toxicology

    Our team of experienced, highly-educated scientists, experts in toxicology, molecular biology, chemistry and immunology, fully understands that the drug development process is distinct for each approach.

    safety pharmacology services

    Safety Pharmacology

    Safety pharmacology satisfies a key requirement in the drug development process, assessing any potential adverse effects that drug candidates may have on the body’s major physiological systems