Creating EU-CTR compliant and patient-friendly lay language summaries (LLS)
Related Insights
Blog
Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development
Jun 22, 2021
Playbook
Streamlining success: How integrated evidence planning transforms asset development
Feb 27, 2025
Blog
New FDA biosimilars guidance: CES waiver pathway aligns with global regulatory approaches
Nov 11, 2025
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Blog
Assessing the need for comparative clinical trials in biosimilar development programs
Sep 21, 2023
Whitepaper
Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
Sep 19, 2023
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Whitepaper
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Webinar
Breakthrough Devices Program: Where’s the value?
Nov 13, 2023
Related Insights
Blog
Breaking through complex regulations and science speak – thinking “patients first” in lay language summary development
Jun 22, 2021
Playbook
Streamlining success: How integrated evidence planning transforms asset development
Feb 27, 2025
Blog
New FDA biosimilars guidance: CES waiver pathway aligns with global regulatory approaches
Nov 11, 2025
Article
The technologies that are reshaping biotherapeutics manufacturing, an EU perspective
Jul 6, 2023
Blog
Assessing the need for comparative clinical trials in biosimilar development programs
Sep 21, 2023
Whitepaper
Scientific Validity Reports: a mandatory requirement for In Vitro Diagnostic Regulation (IVDR)
Sep 19, 2023
Article
Australia: The Regulatory and Reimbursement Environment
Aug 28, 2023
Whitepaper
Optimizing the Route to Regulatory Approval for a Novel Vaccine
Aug 18, 2023
Blog
Ensuring future success in a new market by delivering a robust safety database solution
Aug 4, 2023
Blog
Population variability: important considerations in vaccine development
Jun 14, 2023
Whitepaper
How to prepare for Policy 0070: Challenges and opportunities for clinical data publication in the EU
Jun 28, 2023
Webinar
Breakthrough Devices Program: Where’s the value?
Nov 13, 2023