Confidence Beyond Compliance

With just 6 months to go before the UK’s withdrawal from the EU and the start of the implementation (transitional) phase, the clock is ticking for the pharma and biopharma industries to review their contingency plans. At PharmaLex our expertise covers all aspects of regulatory affairs, pharmacovigilance, supply chain and compliance. With offices in the EU27 and the UK, we are keeping abreast of developments in relation to both future EU and UK regulatory intelligence.

 

Contact us to discuss how we can help you in these challenging times.

EMA simplifies the process for internal transfer of MAs

PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan discusses how the EMA’s simplified process for internal transfer of marketing authorizations may help some Brexit Impacted MAHs.

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Brexit Uncertainty - impact on medicines supply

PharmaLex Vice President Regulatory and Scientific Policy, Jonathan Trethowan looks at what impact Brexit might have on medicines supply across the EU

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Brexit: An update on preparations for MA holders

PharmaLex experts will provide updates for our UK and International audiences answering queries on how, as a Marketing Authorisation Holder (MAH), you can prepare for Brexit. Following the outcome of the UK’s referendum on membership of the European Union, we have analysed the most feasible Brexit scenarios and what their impacts could be for the Pharmaceutical industry.

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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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Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

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