Confidence Beyond Compliance

With 1 year 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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What our clients say

We needed to develop our strategy and PharmaLex had exactly the experience we needed.

Med Device company, UK
Senior QA Director

There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.

Large Pharma, Global
VP Regulatory Strategy