Forms Processing

PRODUCTS

  • We set the industry standard when it comes to commissioning and qualification project delivery.

  • PRISYM 360 is the ONLY labeling solution dedicated to Medical Device and Life Sciences. PRISYM 360 provides organizations with complete label integrity to meet the strictest compliance requirements for FDA and EU regulations.

    By focusing on the data, rather than the label/artwork, PRISYM 360 provides a revolutionary 360° outlook of your master data assets and gives the ability to control and optimize them to create a fully integrated approach across the full label lifecycle.

    Due to the information being data driven, it lets you to find out where content sits quickly and easily, allowing you to deal with mass change. This feature has annually saved customers multi- million dollars on global label change, while reducing the risk of the label carrying old data or using the wrong version.

  • TSI AeroTrak®+ Remote Particle Counters with Pump offer cleanroom professionals top-notch reliability and no-hassle operation in measuring a wide range of particle sizes, including a 6-channel model with upper size threshold of 25 µm. They are designed so that you have critical data at your fingertips—using second-by-second sampling—without worry of data interruption or potential data loss. The reliability of the laser technology inside cannot be challenged as TSI offers the industry’s best laser warranty coverage ever—5 years. All models comply with the stringent requirements set forth in the latest ISO 21501-4 calibration standard.

  • Pii operates over 360,000 square feet of state-of-the-art pharmaceutical development and manufacturing space, all located on one campus in Hunt Valley, MD.  This includes over 70 flexible, manufacturing suites, several with the required containment controls for handling potent compounds and hormones, as well as a dedicated suite for the production of soft gel capsules.  Licensed to manufacture DEA Schedule I-V products, with capabilities for both oral delivery and parenteral dosage forms, Pii has the depth to support development, clinical and commercial requirements.  Facilities are cGMP qualified and include dedicated formulation development centers for solid oral, liquid and sterile products.

  • AST’s GENiSYS® R has a unique blend of automated capabilities to ensure your sterile products, whether clinical or commercial, are processed in strict accordance with cGMP requirements. The system has the flexibility to adapt to your process requirements and container options alike, and its ability to process all ready-to-fill vial, syringe, and cartridge formats allows you to bring drug products to market cost-effectively.

WHITE PAPERS AND CASE STUDIES

  • Foreign Object Detection In Food Inspection And Sorting

    Food inspection, in connection with automated sorting and classification methods has become a major field of application for advanced image capture systems and infrared cameras. This case study tells how Xenics' line scan SWIR camera Lynx is used for copmlex imaging tasks.

  • How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It

    The global pandemic has exacerbated the operational challenges intrinsic to gene therapy at the site level, the project team level, and the sponsor level. To ensure that studies continue to move forward, strategies need to be considered not only for operational efficiency and patient centricity but also as contingency planning in the case of a subsequent wave or quarantine. Here we continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.

  • Insmed’s Fast And Successful EDC Study Builds With Veeva Vault CDMS

    Insmed describes the critical success factors enabling them to incorporate significant protocol changes and still hit their FPI deadline with Vault EDC.

  • CMO Meets Serialization And Aggregation Demands With Case Aggregation Kit

    Pharm Germany GmbH operates as a contract manufacturing organization (CMO), producing and packaging pharmaceuticals for customers which are then distributed in more than 150 countries. This aggregation solution allows them to successfully supply pharmaceuticals to markets that demand serialization or aggregation.

  • Container Closure Integrity Testing: Sensitivity, Automation And Efficiency

    Explore the need for sensitive, reliable, and automated container closure integrity testing technologies, and how existing deterministic solutions can help achieve optimum quality assurance goals.

  • Pesado Goes Mobile, Saves Big.

    Psado's administrative side of the business also racked up high costs and collected field data was vulnerable to inaccuracies. To tighten its business processes, Pesado equipped its field techs with a mobile form solution on iOS devices. 

  • Overcoming Common Challenges Of Clinical Data Review

    Clinical data review is an intrinsic component of clinical development aimed at assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a broad variety of clinical trial data and often necessitates integration of data from multiple sources in order to extract actionable insights. Here, we look at some of the main challenges of clinical data review and discuss effective strategies to address these, before explaining how our solutions can be deployed to bring urgently needed therapeutics to patients faster.

  • Gaining Efficiencies In The Monitoring Visit Report Process

    Ora, Inc. is a full-service research organization specializing in pre-clinical and clinical ophthalmic drug and device development. Learn how Ora implemented monitoring reviewer comments with Veeva Vault CTMS to optimize their trial processes.

  • End Of End Point Assays: SPR Analytics In Vaccine Design, Development

    Discover how SPR can be used to accelerate vaccine discovery and development by helping overcome analytical challenges that have plagued the industry for decades.

  • Making AI Usable For Pharma and Biopharma

    Artificial intelligence (AI) is already making a huge contribution to the global economy, even though this development is still in its early stages. AI is a kind of turbo drive for the new digital technologies, because it enables machines to imitate human decision-making processes. This white paper explores how to use artificial intelligence to uncover hidden business value in the regulated pharmaceutical and biotech industries.

  • Is Wurster Processing The Right Choice For My Multiparticulate Modified Release Dosage Form?

    Wurster processing is a common and appropriate choice for multiparticulate formats. But is it the best one? This paper outlines what you need to consider when determining whether Wurster processing is right for your multiparticulate modified release dosage form, as well as general information to assist in discussions with your CDMO.

  • Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner

    In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.

NEWS