Consultancy and Training White Papers
Stay up to date with the latest Consultancy and Training white papers from the global pharmaceutical industryLatest White Papers
Extractables and Leachables for Medical Devices: Meeting the 510(k) Requirements Recent changes in the FDA's 510(k) requirements for medical device applications have spawned many inquiries from clients on how to address the request for extractables, leachables and...
Analytical Challenges Presented by Leachables from Sample Container Closure Systems in Drug Products Leachables are compounds that migrate into a drug product from the sample container closure system (SCC) under normal storage...
FDA is Increasing Regulations on Excipients Worldwide – What Can Your Company Do to Reduce Risk? Since 2008, when patient deaths were first linked to tainted raw materials used in the manufacture of heparin, the US Food and Drug Administration (FDA) and other regulatory agencies have...
What Will Eventually Wake Up the US Pharma Industry to the Importance of Quality; the Stick, or the Carrot? Roll the clock back to the early 2000s - groundbreaking discussions between FDA and Industry that led to the 'cGMP for the 21st Century' philosophy - science and risk-based approaches to...
Proposed New European Regulation for Medical Devices to Replace 93/42/EEC and 90/385/EEC The Commission proposal for a new regulation to cover medical devices and active implantable medical devices was published on 26 September...
Global Pharmaceutical Survey 2012-2013: Market Trends, Marketing Spend and Sales Strategies This report is the result of an extensive survey drawn from ICD Research's panel of leading pharmaceutical industry...
Global Pharmaceutical Survey 2012-2013: Market Trends, Buyer Spend and Procurement Strategies Overall, throughout the global pharmaceutical industry, 47% of respondents are "more optimistic" about revenue growth for their company over the next 12 months as compared with the previous 12...
Sustainability in the Global Pharmaceutical Industry 2011-2012 Over 2011-2012, buyer sustainability management budgets in the global pharmaceutical industry are expected to rise by...
Automating Life Sciences Compliance Automating Life Sciences...
Regulatory Asset Management: Harmonizing Calibration, Maintenance and Validation Regulatory Asset Management: Harmonizing Calibration, Maintenance and...
Leading Pharma Specialist Selects Microsoft Dynamics and Advantage for Pan European Systems Strategy Leading Pharma Specialist Selects Microsoft Dynamics and Advantage for Pan European Systems...
Microsoft Dynamics NAV is the Meds for Zeneus Pharma Microsoft Dynamics NAV is the Meds for Zeneus...
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