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FEATURED ARTICLES

  • Incorporating Data Integrity into Your Pharmaceutical Quality Management System
    Incorporating Data Integrity into Your Pharmaceutical Quality Management System

    ICH Q10, Pharmaceutical Quality Systems was recommended for adoption to the regulatory bodies of the European Union, Japan and the United States in 2008. EMA then formally approved it that same year. In 2009, the U.S. FDA adopted it as a guidance document. This begs the following question, if companies have adopted the principles of ICH Q10, why have the FDA and EMA been experiencing an increase in the number of data integrity issues found during recent inspections?

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WHITE PAPERS & CASE STUDIES

  • Security Of Pharmaceuticals: A Comparison Of EU And US Standards
    Security Of Pharmaceuticals: A Comparison Of EU And US Standards

    With 840 million inhabitants, and two-thirds of global pharmaceutical sales, the US and Europe are also a lucrative target for drug crime. New sales channels such as the internet as well as global and more complex manufacturing and distribution channels make it increasingly easier for pharmaceutical counterfeiters to market counterfeits directly or to infiltrate the supply chain.

  • How AstraZeneca Improved Validated Workflows In GMP API Manufacturing
    How AstraZeneca Improved Validated Workflows In GMP API Manufacturing

    The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API manufacture.

  • How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management
    How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

    In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.

  • The First Step To Navigating Your Combination Product’s Regulatory Pathway:  PMOA
    The First Step To Navigating Your Combination Product’s Regulatory Pathway: PMOA

    The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.

  • Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

    Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.

  • 3 Tips For Safe, Secure Healthcare Shipping
    3 Tips For Safe, Secure Healthcare Shipping

    All businesses need their shipments to go smoothly — nothing damaged, lost or late, and no last-minute surprises. And this is especially true in the healthcare sector, where a shipping mistake can cost not just dollars, but the health of a patient. By FedEx Custom Critical

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PRODUCTS & SERVICES

Enterprise Asset Performance Management Software for Life Sciences, Pharma Enterprise Asset Performance Management Software for Life Sciences, Pharma

Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.

Life Sciences, Pharmaceutical Regulatory Compliance Software And Services Life Sciences, Pharmaceutical Regulatory Compliance Software And Services

The Schneider Electric team of dedicated industry experts is focused on providing companies with strict regulatory adherence in a timely and cost-effective manner. This includes comprehensive regulatory compliance and validation services, focused on but not limited to, environmental monitoring systems, building management systems, manufacturing, processing and packaging equipment and automated business systems (MES, laboratory, Information Technology). The Schneider Electric offerings for life sciences also include quality audits and assessments. Our full range of services and solutions are vendor and platform independent, providing organizations , such as pharmaceutical and biopharma manufacturers with an objective and authoritative view.

Pharmaceutical Cyber Security Services Pharmaceutical Cyber Security Services

Schneider Electric addresses an organization's compliance and cyber security challenges from analysis through to implementation and management. We start by providing expert consulting with a track record of global success to assess the current compliance situation. We then define an overall Cyber Security plan and remediation strategy encompassing processes, procedures, people, products, networks and applications.

NDA Approval And Post Approval Services NDA Approval And Post Approval Services

From 2006 through 2015, Patheon helped clients earn 92 NDA approvals. That’s  twice as many as any other CMO. Success brings more success at this stage. That’s because depth of experience, reliability of quality and refinement of processes are all important in the final push for regulatory approval and making the transition to commercial manufacturing.

EZ BioPac™: Powder Transfer Process EZ BioPac™: Powder Transfer Process

Advanced Powder Transfer for Media and Buffer preparation and Solids additions.

Regulatory Services Regulatory Services

If you need help preparing and submitting your API regulatory applications, Cedarburg Hauser Pharmaceuticals has the knowledge and experience it takes to efficiently guide you through the complexities of the FDA submission process.

Regulatory Regulatory

JHP Pharmaceuticals has an experienced in-house Regulatory Affairs department capable of assisting you with Clinical Trial Applications, New Drug Submissions, and Supplements.

Adverse Event Reporting, Safety and Compliance Software Adverse Event Reporting, Safety and Compliance Software

Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.

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