Our Articles
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.
BIO 2022 Round Up
From the 13th - 16th June, our Director Paul Cronin, Chief Financial Officer Charles Camp CGMA and Business Development Manager Stuart Hunter returned to Scendea’s largest event of the year, BIO 2022.
The Importance of Regulatory Strategy
Getting a new drug to the patient involves numerous stakeholders that are part of a multi-faceted regulatory framework. This framework has evolved over time and proceeds from drug discovery to development to regulatory evaluation.
Scendea Team Getaway
The 2022 Scendea Getaway was a fun-filled weekend spent enjoying time together as a team, learning about our new members and stepping out of our comfort zones.
Drug Device Combination Products - Navigating Regulatory Challenges and Pitfalls in the EU
Drug-device combinations (DDCs) are products that include both a medical device and medicinal product constituent part. There are two main types of combination products: Integral and Co-packaged.
Clinical Trial Regulation
From 31 January 2022 CTA submissions under the Regulation can start; at this point Sponsors have the option of filing under the new the Regulation or the existing Clinical Trial Directive (‘the Directive’).
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.
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.
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.
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.