Product Safety/Pharmacovigilance

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    Analytical Services

    Our team’s expertise and on-site laboratories are equipped with state-of-the-art instruments.

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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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    Full-Service CRO Services

    As a top Clinical Research Organization, ProPharma brings over 20 years of experience, innovation, personalization, and adaptability to Sponsors’ studies and research.

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    Combat Nitrosamine Challenges With Comprehensive Analytical Solutions

    As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.

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    Process Insight Born Of 45 Years Of Experience

    Mikart’s analytical services begin with accurate measurements of formulation characteristics and are informed by our dedicated team’s mastery of process — the precise changes that maximize your product’s performance and market adoption.

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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.