Product Safety/Pharmacovigilance

PRODUCTS

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    Pivotal Toxicology Studies

    Leveraging extensive expertise and state-of-the-art facilities, Altasciences conducts comprehensive toxicology evaluations to ensure the safety and regulatory compliance of your novel drug candidates.

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    PIC/S GMP Production

    Mycenax’s state-of-the-art biomanufacturing site is PIC/S GMP certified. Our highly qualified and well-trained team routinely manufactures high-quality biopharmaceutical products by mammalian cell culture and microbial fermentation processes. We continuously invest in our technologies and infrastructure to ensure that we constantly meet your evolving needs of today and tomorrow.

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    Stability Testing – Onsite Preclinical Services To Support Your Product Development

    Natoli Scientific’s preclinical stability studies represent a critical facet of our pharmaceutical testing services, providing essential data on the shelf life and storage conditions of drug candidates. These studies are expertly designed to evaluate physical, chemical, and microbiological stability, ensuring that formulations retain their safety, efficacy, and quality over time. Our state-of-the-art facilities simulate various environmental conditions to scrutinize the integrity of products under stress-testing scenarios. The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.

  • 3P Innovation - Fill2Weight
    Gravimetric Powder Filler: Fill2Weight

    Fills syringes, vials, cartridges, capsules and custom containers at speed with aseptic powder micro-dosing technology.

  • Safety & Pharmacovigilance Solutions
    Pharmacovigilance

    The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.

WHITE PAPERS AND CASE STUDIES

NEWS

ABOUT

Pharmacovigilance/Drug Safety
Pharmacovigilance is also referred to as drug safety. Drug safety is the pharmacological science around the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical substances.
The primary focus of pharmacovigilance is adverse drug reactions. Adverse drug reactions include any response to a drug that is harmful, poisonous or unintended. Unintended consequences can include lack of effectiveness at a therapeutic dosage, overdoses, abuse or misuse of the drug.
Adverse event reporting is the activity most closely associated with pharmacovigilance. Adverse event reporting consumes a significant amount of time. It involves the notification, prioritization, data entry, hazard assessment, distribution, reporting and archiving of the adverse event and all related data and documentation.
In order to improve the outcomes of clinical trials safety and risk management receive greater amounts of resources and money. The pharmacovigilance function is an integral part of creating safety oversight throughout all phases of a clinical trial.  This function requires great efficiency, and a seamless, integrated framework to ensure rapid, early detection and reporting of adverse events, assessment and follow-up.
Clinical trials, with a strong pharmacovigilance process, result in lower surveillance costs during the product development cycle, and enhance patient safety by communicating potential safety issues quickly.  With tight drug safety vigilance in place, problems are identified and addressed quickly; reducing the time it takes to get a product into the marketplace.


The ultimate job of pharmacovigilance is the identification of hazards associated with pharmaceutical products and finding ways to minimize risks or harm to patients.