Product Safety/Pharmacovigilance
PRODUCTS
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Our team’s expertise and on-site laboratories are equipped with state-of-the-art instruments.
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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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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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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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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.
WHITE PAPERS AND CASE STUDIES
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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Extractables And Leachables Testing
Learn how to navigate the extractables and leachables regulatory landscape and implement best practices for leachables analysis in your pharmaceutical development process.
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A Shift Towards Biofluorescent Particle Counters In Manufacturing
Sterility in injectable drug manufacturing is vital for patient safety and efficiency. Discover how biofluorescent particle counters revolutionize contamination control, regulatory compliance, and operational excellence in modern pharma.
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Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology
Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.
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Quality By Design: The Importance Of Reference Standards In Drug Development
Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.
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Revolutionizing Drug Discovery From "Undruggables" To AI
Explore four current trends in drug discovery, how each trend addresses some of the most crucial challenges in drug discovery, and the obstacles to their widespread adoption.
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Seizing Market Share Pre-Patent Expiry: The Evolution Of A CDMO Partnership In Navigating A Paragraph IV ANDA Submission
The dynamic pharmaceutical landscape demands agility and strategic foresight. Explore how leveraging a key partnership helped to overcome a looming patent expiry for a second-generation acne medication.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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In Vivo Testing Of Nasal Dosage Forms
Innovative nasal drug delivery strategies can unlock faster, patient-friendly therapeutic solutions by combining smart formulation, advanced testing platforms, and rigorous preclinical evaluation.
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Proximity Inducers In Drug Discovery - A Perspective On Cooperativity
Overcoming the limitations of current proximity inducers requires optimizing cooperativity. Learn how enhancing target affinity can lead to smaller, more effective therapeutics with better safety profiles.
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Beyond Traditional Monoclonal Antibodies
New antibody formats present new purification challenges due to novel impurity profiles. New methods and media are required to ensure safe, effective, and scalable manufacturing of these biologics.
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The Relevance Of Polymorph Screening In The Pharmaceutical Industry
Polymorph screening identifies different solid forms of active pharmaceutical ingredients, optimizing drug stability, solubility, and manufacturability. This process ensures quality, regulatory compliance, and intellectual property protection in pharmaceutical development.
NEWS
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Nutriband And Kindeva Drug Delivery Formalize Exclusive Development Partnership For Aversa™ Fentanyl Abuse Deterrent Fentanyl Patch2/13/2025
Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has signed an addendum to the Commercial Development and Clinical Supply Agreement for its lead product, Aversa™ Fentanyl, that it has in place with its partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.
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Biocon Biologics' Yesafili (aflibercept) Now Publicly Funded In Ontario, Canada For The Advanced Treatment Of Patients With Retinal Diseases9/18/2025
Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., is pleased to announce that Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases in Canada.
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Shionogi Submits Supplemental New Drug Application For Ensitrelvir In Japan For The Post-Exposure Prophylaxis Of COVID-193/27/2025
Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter “Shionogi”) submitted today supplemental New Drug Application (sNDA) in Japan for its investigational, oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.: S-217622, hereafter “ensitrelvir”) for post-exposure prophylaxis of COVID-19.
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Prometheus Laboratories Announces Collaboration With Celltrion For Anser Testing8/27/2025
Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, today announced a collaboration with Celltrion USA, Inc. ("Celltrion USA") to validate and expand the upper limit of quantitation for Anser IFX (infliximab) therapeutic drug monitoring (TDM) testing for patients receiving ZYMFENTRA (infliximab-dyyb).
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Bavarian Nordic Receives U.S. FDA Approval Of Freeze-Dried Smallpox And Mpox Vaccine3/31/2025
Bavarian Nordic A/S today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older.
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.