Medical Devices for the Pharmaceutical Industry

PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize
and customize quality and regulatory solutions which are delivered on time, in budget and with the highest quality.

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Medical Device Regulations Transition Support

The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team are available to provide support as required.

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Veeva Vault RIM Implementation

Limited internal resources and minimal experience with RIM implementation projects

  • US-headquartered biopharmaceutical company with European affiliate
  • First NDA approved; further, NDAs planned
  • Fast-growing company with increasing Regulatory needs
  • Limited resources for project management and operational work during configuration and implement phase
  • Minimal experience with RIM implementation projects and no experience with Veeva Vault

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VIGISCREEN - Automated and intelligent processing technology

VigiScreen is a cloud-based software solution that processes incoming ICSRs, automating the analysis of company vs non-company cases, reducing screening workload by up to 80%. A GxP validated system according to GAMP 5 guidelines, CFR Title 21 Part 11 compliant.

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PharmaLex Overview of Services

We are global provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance.

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Regulatory Submissions for Tobacco and Vape Products

PharmaLex offers regulatory compliance services that address the new FDA requirements that have been implemented to govern the tobacco and vape industry.

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Regulatory Affairs Application Services

There are strict regulations worldwide that set the framework on how to reach market access. Our regulatory affairs team offers profound knowledge to develop the optimal…

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Health Authority Interactions

Each scientific advice from health authorities – be it during drug development, the marketing authorization process or later during the life-cycle of the drug – might…

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Regulatory Compliance

Pharmaceutical companies are marked by factors such as external changes in the regulatory environment and internal Merger & Acquisition programs, entry into new markets (especially non-ICH regions) or changes…

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Chemistry, Manufacturing and Control (CMC)

Our CMC group provides regulatory guidance in setting specifications, method development and validation of documentation. We can help you build a positive relationship with…

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Medical Device Services

Read about our full range of Medical Device services.

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