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Explore our thought leadership article library, where you can find a wealth of insights on regulatory intelligence, industry updates, and the latest pharmaceutical and biotechnology developments.

Tom Allport Tom Allport

BIA/MHRA Regulatory Innovation Conference

In July 2021, MHRA published their two-year roadmap: ‘Medicines and Healthcare products Regulatory Agency Delivery Plan 2021-2023; Putting patients first: A new era for our agency’, within which scientific innovation, healthcare access and patient safety were called out as top priorities.

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Tom Allport Tom Allport

Regulatory Aspects of Paediatric Drug Development

Paediatric drug development is a complex and challenging process, due to ethical, methodological, operational and financial limitations. Paediatrics are not a uniform sub-group and the medical needs, biological and physiological characteristics of neonates, for example, are very different to that of adolescents.

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Tom Allport Tom Allport

Approaches and Regulatory Considerations

Successful approval of biological medicinal products in the EU and US require characterisation of biological products’ properties to enable the setting of specifications that control the molecule’s critical quality attributes (CQA) for release into the clinic and onto the market.

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Tom Allport Tom Allport

Biosimilar Development: Commonly asked Questions & Answers.

A biosimilar is a biological medicine that is highly similar to another biological medicine already approved. With a large number of blockbuster innovator products reaching their patent expiry dates in the next 10 years, biosimilar development continues to be a highly lucrative field.

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