Analytical Testing

Pharmaceutical Outsourcing Analytical Testing - Laptop Showing Data

Analytical testing services outsourcing allows pharmaceutical innovator companies to handle more complex tasks in-house while also assisting companies in concentrating on their core competencies, enabling pharmaceutical companies to avoid developing specialized facilities and hiring staff, results in cost savings.

Specifically, pharmaceutical analytical testing refers to quantifying and identifying components in pharmaceutical drugs and solutions. The goal is to ensure products meet FDA regulations for safety, potency, purity, and stability.

Analytical development and testing services may also include method development, method transfers, qualification and validation services.

Filter

Hide Filter

  • The Rise of Patient Engagement in Clinical Trials

    Monday, November 30, 2015
    Patient engagement, which has alternatively been known by many names, including patient centricity and patient activation, refers to the process of involving and empowering patients to improve their health care. By improving patient engagement, it... read more

  • Alphora Research Inc. Completes 3,000 Sq. Ft. Analytical Laboratory Expansion

    Wednesday, November 18, 2015
    Alphora is pleased to announce the completion of a new 3,000 sq. ft. analytical laboratory expansion. read more

  • Forming a Solid Communication Channel with Third Party Vendors

    Wednesday, September 30, 2015
    As the use of third party vendors continues to increase, the necessity of a strong communication network is apparent. A 2015 article by Cutting Edge Information stated that The Association for Clinical Research Organizations estimates sponsor use ... read more

  • When Things Go Wrong: Planning for the Unexpected

    Wednesday, September 30, 2015
    Attend any conference dealing with the pharmaceutical industry, from new drug discovery to API and drug product manufacturing, and you will hear presentations outlining successful programs and stunningly brilliant research and development. These ... read more

  • Techniques, Challenges and Strategies in Comparator Blinding

    Wednesday, September 30, 2015
    Commercially marketed drug products are often used in clinical trials in direct comparison with an investigational medicinal product. As defined in regulatory guidance, a comparator is “an investigational or marketed product (i.e. active control),... read more

  • The Contract Service Provider Compact

    Wednesday, September 30, 2015
    Contract manufacturing organizations are our industry partners. There are few strategic and tactical plans within the global life sciences that do not include an outsourcing element. The maturation of the Indian and Chinese markets has created ... read more

  • Becoming a Partner of Choice

    Friday, July 31, 2015
    Imagine you are working or traveling away from your home when an emergency repair crops up. You can’t handle it personally, but you know someone who can – and one call to that person takes care of it. read more

  • The Unintended Inefficiencies of Outsourcing Practice

    Friday, July 31, 2015
    Historically, the decision to hire contract service providers was driven in large part by the need to employ variable capacity and to gain access to scientific and geographic expertise. read more

  • Understanding Special Protocol Assessments

    Friday, July 31, 2015
    The Guidance for Industry: Special Protocol Assessment (SPA) was issued in May of 2002, with the express purpose of enabling the Food and Drug Administration (FDA) to provide input into the design of certain studies critical to marketing approval ... read more

  • Establishing and Managing the Drug Product Stability Budget

    Friday, July 31, 2015
    How long can a pharmaceutical product be exposed to temperatures outside the recommended storage conditions? How can product discard be prevented in cases of temperature excursions? How to establish and to manage the allowed time out of storage of... read more

  • Selecting and Working with CMOs for Complex Formulations and Processes

    Friday, July 31, 2015
    Over the past couple of decades, the pharmaceutical and biotech industries have trended towards increasing outsourcing of clinical and commercial materials and services. read more

  • Marken and Acres Announce Partnerships Streaming Clinical Trial Logistics

    Thursday, June 11, 2015
    Marken, the leading clinical logistics organization, and the Alliance for Clinical Research Excellence and Safety (ACRES), a multi-sector non-profit dedicated to excellence in clinical research, have created a strategic partnership with the goal of ... read more

  • The Increasing Shift of Clinical Trials to CROs

    Thursday, May 28, 2015
    In the last decade, industry has changed operations of clinical research from a vertical and fixed reporting model, with a large number of in-house professionals dedicated to clinical studies, to a matrix model involving both internal and external ... read more

  • HORIZON LINES: A Quarterly Review of NDAs - 4Q14

    Thursday, May 28, 2015
    This column summarizes New Drug Applications (NDAs) for the Fourth quarter 2014 (October through December 2014). In this quarter, FDA approved 46 NDAs. read more

  • Maintaining the Relationship with a CMO

    Thursday, May 28, 2015
    Successfully navigating the setting up and use of contract manufacturing organizations (CMOs) is a daunting task, or actually, tasks. Over the years I have set up and managed these relationships successfully and now as a consultant I am often ... read more
Page