Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.
Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.
Larger pharma organization have evolved into hierarchical silos due to a combination of legacy organizational structures, mergers and acquisitions, and lack of a holisitic approach to innovation.
3D printing allows drug companies to not only boost efficacy and adherence but also contribute to their brand longevity by expanding and capturing market share with other dosage form options.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
Everyone is fixated on streamlining production processes and reducing the bottom line. This means getting new instruments into the workflow as soon as possible.
While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.
Avoid production quality-related issues by understanding and knowing how to identify the most common causes of punch tip edge wear.
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
Pharma Packaging Solutions helps companies create packaging which deals with dosing regimens, patient instructions, patient record keeping and more. For companies needing unique designs to drive medication adherence, there is in-house Creative Service Team to develop specified artwork.
The HygroClip2 ADVANCED humidity and temperature probes offer you maximum repeatability and an accuracy of ±0.8 %RH and ±0.1 K.
Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.
The Schneider Electric team of dedicated industry experts is focused on providing companies with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, Information Technology). The Schneider Electric offerings also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing organizations with an objective and authoritative view.
Metrics Contract Services offers a complete elemental impurities program designed to comply with the USP 232 and USP 233 Elemental Impurities proposed chapters which become official on December 1, 2015.
Advanced Powder Transfer for Media and Buffer preparation and Solids additions.
If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.
This presentation discusses the basic definitions of extractables and leachables and why it is important to reference the vast amount of reference material available to ensure that you are meeting industry standards. Understand the role of the supply chain, what departments/positions within your company need to be involved, as well as many other factors to consider such as the machine, drug substance, material, water, and container closure system environment when designing your extractable/leachable study.
This presentation discusses some basics of cell-based assay and why it's the preferred method to support potency analysis for bio therapeutic drugs; developing and optimizing cell-based potency assay; understanding phase appropriate method validation as well as an overview of the typical workflow to transfer cell-based potency assay into a GMP environment and best practices to maintain the long term performance of the assay.
Using workflow based software solutions to guide scientists through various processes in low to high throughput screening campaigns.
This webinar explores use cases showing how machine learning and analytics can help overcome the challenges facing the biopharma industry through more confident data-driven decisions.
Pilgrim Software, Inc., a leading provider of cloud and on-premise enterprise quality management solutions, recently announced it is formally changing its name to Pilgrim Quality Solutions and will begin operating under the new trade name effective immediately.
Tapemark is pleased to announce the addition of several new capabilities for transdermal patches, including the formulation, blending, and coating steps in the patch manufacturing process.
EMC Corporation recently announced that Sanofi Pasteur, a world leading vaccine manufacturer producing more than 1 billion doses of vaccine per year, has deployed EMC® Documentum® D2, enabling the company to accelerate time-to-value through the power of configuration.
The U.S. Food and Drug Administration today issued a Warning Letter to The Avalon Effect Inc., a company based in Franklin, Tenn., for its marketing of a light therapy product that claims to cure or treat symptoms of fungal meningitis, methicillin-resistant Staphylococcus aureus (MRSA), concussions, Lyme disease, and other diseases.
Flamel Technologies SA (NASDAQ: FLML) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for an undisclosed hospital-based product.
Coding for Compliance Domino prepares you for ePedigree.
PCI is a market leader in the provision of Cold Chain management services and has extensive capacity and unrivaled expertise to accommodate our client’s refrigerated and frozen storage and distribution requirements.Our extensive Cold Chain storage areas are all fully validated, continuously monitored and alarmed, and offer different storage temperatures, from Controlled Ambient (15-25°C) right down to -196°C.
Today’s Life Sciences industry is facing major challenges like patent expirations and low R&D productivity, increasing competition globally and decreasing margins, as well as non-optimized processes and compliance pressure.
Managing and leveraging biologics data, especially in development, is challenging as experimentation generates a large amount and wide variety of complex data while scientists must track genealogies within this complex stream of data to arrive at an end entity.
