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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