PharmaLex Overview of Services

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

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InnoPHLEX

The end-to-end solution for specialized pharma and biotech

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SourcePHLEX

The one-stop global solution for pharma and biotech companies looking for portfolio maintenance

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ATMP Quick Links and Guidelines

Links to ATMP guidance by national authority

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Biosimilar Quick Links and Guidelines

Links to Biosimilar guidance by national authority

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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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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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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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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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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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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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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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Writing Capabilities

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

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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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Portfolio Maintenance Outsourcing

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

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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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Procurement

Benefit from PharmaLex’s global resources to help you realize your targets today and beyond.

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Brexit General Flyer

The UK’s prospective withdrawal from the EU (“Brexit”) is the subject of Q&As and practical guidance issued by the European Medicines Agency. At PharmaLex, we will address your requirements systematically and…

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Medical Device Services

Read about our full range of Medical Device services.

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Medical Device Services - RA / QA Maintenance

Choose the level of support that meets your needs to complete maintenance activities including: Site Registrations, Product Listings, Export Certificates…

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Medical Device Services - RA / QA Consulting

Choose the level of QA/Compliance and/or RA support needed throughout the year on an “as needed” basis.

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Medical Device Services - Auditing

Choose the level of audit support that meets your needs at both manufacturer and supplier sites…

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Medical Device Services - Outsourcing

We will work with you to develop an outsourcing solution that is right for your organization.

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