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WHITE PAPERS & CASE STUDIES

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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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