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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What should you know about the Trial Master File: a refresher
The Trial Master File refers to a repository of documents that collectively can be used by monitors, auditors, assessors and…
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Are you making the most of the incentives and benefits that are available to support…
The importance of SMEs is nicely captured in a quote by Jean-Claude Juncker, President of the European Commission: We must…
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The Microbiome Journey: Development of a Food Product with Health Claims
The microbiome and its relationship to the maintenance of health is a topic that continues to gain more and more…
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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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