Compliance

PRODUCTS

  • The MPD2-00001PSM is a small footprint MMIC 2-Way Wilkinson power divider/power splitter featuring high isolation in our compact DFN package.

  • The dB-8059 is a wideband Gallium Nitride (GaN) Solid State Power Amplifier (SSPA) engineered for high-power performance across a broad frequency range of 2.0 to 18.0 GHz.

  • A strong risk and quality control strategy is essential to ensuring the safety, efficacy, and consistency of pharmaceutical manufacturing. By identifying and addressing potential risks early, we prevent costly errors and delays, ensuring smooth and efficient manufacturing of your products.

  • Whether you’re conducting an oncology trial, a neurology study, or imaging-based endpoint research, TrialKit’s flexible imaging capabilities can meet your needs.

  • We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

WHITE PAPERS AND CASE STUDIES

  • GFI Case Study: Montclair Board of Education Montclair Public School District, is recognized by the United States Department of Education as one of the six best magnet school districts in the country with a group of schools falling under this umbrella name that accept students ranging from ages 5–16. Over 2,000 employees using email extensively and with...
  • Improving Global Labeling Workflow

    One of the leading suppliers of medical devices to the orthopedic market has been working with label lifecycle management solution provider, PRISYM ID to help implement a compliant label solution with validated label processes for its product portfolio. The company manufactures and delivers products with a wide range of capabilities including joint replacements, spine and micro implant systems, orthobiologics, powered surgical instruments, surgical navigation systems, endoscopic products as well as patient handling and emergency medical equipment. After looking at the company’s requirements, PRISYM ID implemented a solution to ensure regulatory compliance and the automation of the labeling functions.

  • Support Manufacturing Operations With Process Data Management Software

    Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).

  • Protect Your Health Records And Meet Your Compliance Obligations Compliance claims made by vendors concerning their products can be misleading. Below are excerpts from HIPAA’s Technical Safeguard’s that refer to requirements that a compliant storage solution should address. In violet are the capabilities Nexsan Assureon provides its customers. Submitted by Nexsan Technologies
  • Physicians Medical Group Cuts Processing Time With Datacap Taskmaster Physicians Medical Group of Santa Cruz County (PMG) cut its claims processing time by more than half and provided faster access to data, fewer compliance concerns, happier employees and more satisfied customers with an integrated solution from Datacap and Bowe Bell & Howell. Submitted by Datacap
  • TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
  • Delivering Lifesaving Intravenous Therapy Across The USA Within 24 Hours

    The goal was to successfully deliver time-critical intravenous therapy, Legalon, from a GMP Philadelphia depot to sites across the USA to treat patients suffering from amatoxin poisoning.

  • Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation

    Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.

  • Case Study: Excavating Company Gains Environmental Compliance For Vehicle Wash Water Brownsville, Penn.-based, Brubacher Excavating, Inc. performs a full range of excavating, pipe and utility installation, roadway construction, general earth moving activities and related site development services in Southeastern Penn. Although the company washes its heavy equipment regularly, its dump trucks and tractors account for the most frequent use of its wash bay.
  • Fire And Life Safety And Security Industry

    New government regulations and the need to update outdated or non-compliant technology are requiring building owners and facilities managers to think about upgrading their fire alarm, security, and fire suppression systems with the latest technology available.

  • Serialization And Traceability Compliance In Pharma And Med Device

    Explore the role of traceability and serialization and the benefits they offer beyond compliance. Further, gain perspective on how to approach UDI implementation and choose an appropriate solution.

NEWS