PharmaLex Overview of Services

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

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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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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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Writing Capabilities

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

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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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