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.

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  • Environmental Monitoring: An Evolving Process for Today’s Evolving Production

    Sunday, November 20, 2016
    As pharmaceutical manufacturing becomes increasingly globalized, with companies engaging both contract development and manufacturing organizations (CDMOs), as well as contract research organizations (CROs) in multiple countries, contamination ... read more

  • Sample Handling and Processing: Its Impact on Bioanalytical Test Results

    Friday, September 30, 2016
    When clinical trials were first developed to test the effectiveness of drugs in treating diseases, it was usual to carry out tests using multiple drug samples, including for pharmacokinetics (PK) and other assessments such as pharmacodynamics (PD). ... read more

  • Ensuring Data Quality in an Outsourcing Environment

    Friday, September 30, 2016
    The hurdles and costs associated with bringing a drug through the development and approval process have skyrocketed. Over the past forty years, the average cost of running a preclinical program has jumped from hundreds of millions of dollars to ... read more

  • The CMO/Sponsor Relationship: How to Strike the Perfect Balance

    Friday, September 30, 2016
    The roles of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are growing at light speed as pharma, life sciences and biotech firms of all shapes and sizes discover the benefit of outsourcing key functions in the... read more

  • Biopharmaceutical Manufacturing Globalization Continues

    Friday, September 30, 2016
    Around 45% of biopharmaceutical manufacturing organizations expect to off-shore at least some of their operations over the next five years, with the figure dependent on the nature of the activity, according to BioPlan Associates’ 13th Annual Report ... read more

  • CMO/CDMOs: Looking Ahead

    Friday, September 30, 2016
    The number one trend from last year’s edition demands a repeat (see - (http://pharma-bio.org/pdfs/CPhI%20annual%20report%202015.pdf - page 46). The CMO/CDMO sector remains fragmented, and business logic dictates that the sector needs to consolidate (... read more

  • Hard Truths about Executing Outsourcing Relationships

    Thursday, July 21, 2016
    By far the fastest growing area of R&D spending is outsourcing. Exceeding $60 billion in 2016, sponsor company spending on contract R&D services is growing at six times the annual rate of spending on internal staff, infrastructure and technology ... read more

  • Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies

    Thursday, July 21, 2016
    Critical reagents are essential components of ligand binding assays (LBA), and include many reagent categories including antibodies, engineered proteins, conjugated proteins, chemically synthesized molecules, complex biologics, and solid-supported... read more

  • Horizon Lines: A Yearly Review of NDAs - 2015

    Thursday, July 21, 2016
    For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. This column summarizes ... read more

  • What Are the Latest Guidelines for Excipients?

    Thursday, July 21, 2016
    The global outlook for excipients looks bright, as the market is expected to grow at an annual compound rate of of 7.6% from 2015 to 2020, reaching $6.4 billion by 2020.1 The major factors driving market growth are the growing demand for ... read more

  • Coming Clean on Quality in the Chemical Manufacturing Lab

    Thursday, July 21, 2016
    The price of ensuring quality in chemical manufacturing goes far beyond cost. Hopefully, quality problems are caught before they can affect patients but even then, such problems can make or break a manufacturing organization. In the U.S., while it... read more

  • Keys to Successfully Negotiate Site Budgets and Contracts

    Monday, May 30, 2016
    Study budgets and contracts are complex business processes. Both are generally created by the sponsor and provided to the site; however, the authors regularly advise study sites that neither document is set in stone and should be approached as a ... read more

  • The Five Competencies of Continuous Regulatory Compliance

    Monday, May 30, 2016
    Look at any country or region with a strong generic pharmaceutical and active ingredient manufacturing sector, and you are sure to see a diverse industry with business models that range across a spectrum. That spectrum is typically comprised of ... read more

  • CMOs and Innovation

    Monday, May 30, 2016
    Contract manufacturing organizations (CMOs) are typically on the leading edge of new biopharmaceutical manufacturing technology adoption, as evidenced by many CMOs hiring for positions like ‘technology scout’ and ‘director of innovation’. CMOs ... read more

  • Benefits and Hurdles In Implementing An Automated Clinical Sample Tracking System

    Monday, May 30, 2016
    It’s not news to anyone in the pharma or biotech industries that clinical trials have become increasingly complex over the last decade. With the shift towards precision medicine, greater emphasis on exploratory endpoints, and trials with multiple ... read more
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