We like to keep our readers up to date on complex regulatory issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision.
Latest Blog posts
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Microbiome health products: drugs or foods?
Considerations on the development of pharmaceuticals and foods designed to favourably impact the human microbiome – health claims, legislation and…
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How to Choose a Medical Writer?
A medical writer is an essential part of any project team involved in developing a product to market and beyond.…
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New regulations for IVD Manufacturers when developing new devices
New requirements of the European regulations: demonstration of clinical evidence To improve the health and safety of patients and users,…
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Medical Writers brace themselves for new EU regulations
Some of the current ‘hot topics’ discussed at the 46th European Medical Writers Association (EMWA) conference in Barcelona included the…
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Do I need to comply with Policy 70 ?
It remains the mission of all stakeholders to get high-quality medicines to patients as time- and cost-efficiently as possible. To…
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Update on The Redistribution of UK’s portfolio of centrally authorised products
In preparation for Brexit, the 27 EU Member States, together with the European Medicines Agency (EMA), have reached a major…
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EU Downplays likelihood of UK staying in EMA after Brexit
In draft guidelines prepared by the President of the European Council, and published on 7 March 2018, the European Council…
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Brexit update: EMA & Join Trade Association Meeting on 23rd March 2018
We are on the home-straight to Brexit! Just one year (30th March 2019), to the official date in which the United…
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