FDA meetings and health authority interactions

Meetings with the leadership and review staff of the US Food and
Drug Administration (FDA) are one of the most important resources
available to sponsors seeking agency approval in the US. PharmaLex
recommends holding face-to-face and teleconference meetings with
FDA throughout the product development timeline.

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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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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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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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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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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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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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Regulatory Compliance - CMC Implementation

Implementing a sustainable approach to the CMC compliance process. CMC compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors.

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Health Economics

Early advice on health economics, reimbursement and market access strategy.

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Biosimilar Quick Links and Guidelines

Links to Biosimilar guidance by national authority

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ATMP Quick Links and Guidelines

Links to ATMP guidance by national authority

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Medical Device Services

Read about our full range of Medical Device services.

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Medical Information Services

Our extended product portfolio can serve various needs and varies from service models that help to streamline and support internal processes to successful product launch.

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Portfolio Maintenance Outsourcing

PharmaLex provides a viable Strategic Outsourcing solution, capable of maintaining your products throughout the life cycle while…

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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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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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Writing Capabilities

PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.

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Real World Evidence

In contrast to the controlled and homogeneous setting in RCTs, the real-world setting consists of a broader and more representative patient population, where treatments are not necessarily used in accordance…

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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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GxP - Operate a functional and efficient Quality Management System

A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical…

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Value Added Medicines

Value Added Medicines developments aim at enhancing well-established, off-patent molecules by optimizing their efficacy, tolerability, or ease of use or even exploring them in new indications.

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Orphan Medicine Development

Orphan medicines are intended to treat rare diseases. Both, the EU and US drug legislation have financial and regulatory incentive systems in place to…

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Advanced Therapies - Navigating through the Regulatory Framework

The ATMP regulatory framework in the EU and the US framework programs for cell-based or gene therapy products are complex…

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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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Biopharmaceuticals CMC

Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the…

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