Thought Leadership
Journal Article
Health authorities are turning to digitalization to streamline their processes in response to global crises (such as the COVID-19 pandemic) that have affected the supply chain. The growing complexity of information and data in regulatory submissions has encouraged health authorities to implement structured data submissions and centralized e-submission processes through shared workspaces (1, 2). Some ongoing initiatives seek to simplify review and assessment processes through increased global cooperation and harmonization.
Infographic
Time is rapidly running out to transition ongoing clinical trials in the EU to the new framework of the Clinical Trials Regulation (CTR). A key challenge for sponsors is ensuring they are proficient in the Clinical Trial Information System (CTIS) and understand the transition requirements.
Blog & Article
- 22nd March 2024
Journal Article
Check the different validation models in our industry and the specific models to follow.
Blog & Article
- 13th March 2024
Journal Article
In the two decades since biosimilars emerged on the world stage, their evolution has brought acceptance of the critical role they can play in making life-changing therapies more affordable.
Blog & Article
- 11th March 2024
Journal Article
The steps involved in manufacturing pharmaceutical products require rigorous processes to ensure the safety of patients. One important such process is cleaning validation — a critical element in current good manufacturing practice (CGMP).