Thought Leadership
White Paper
Targeted medicines represent a class of treatments designed to specifically target individual disease conditions such as molecular or genetic alterations that drive disease progression. Unlike traditional therapies, which typically have broad effects on both healthy and diseased cells, targeted therapies aim to selectively address the aberrant signaling pathways or biological processes underlying a particular disease or disease subgroup.
Infographic
Regulatory requirements for combination products vary significantly by region, and registration frequently necessitates a dual assessment approach. We can manage the intricacies of borderline products and navigate unique regulatory pathways in all major markets.
Journal Article
While regulatory authorities are increasingly adopting reliance programs to asses applications, few offer the opportunity to take advantage of simultaneous assessment and approval timelines across borders and jurisdictions.
Journal Article
The electronic Common Technical Document (eCTD) is 16 years old, approved by the International Council on Harmonisation (ICH) to Step 4 in 2008. It’s old enough to drive a car in the US. It’s had some small changes over the years but is still pretty much the same as it was in the George W. Bush era. It’s had a huge impact on the speed and accuracy of regulatory submissions for pharma … but it could be better. That same year, the US Food and Drug Administration (FDA) started looking at a next-generation submission format, which would become eCTD 4.0. That standard
Journal Article
Combination products are integral to the healthcare system and play an increasingly important role in patient safety and medicinal usability, enhancing therapeutic benefits and improving outcomes.
Journal Article
Technology transfer is a sophisticated and complex undertaking that requires careful planning to ensure successful transition and regulatory compliance.
Blog & Article
- 4th July 2024