astellas

Companion Diagnostic Studies Under IVDR: Regulatory Requirements, Study Design, and Clinical Evidence Generation

Beyond “Inactive”: Mastering Type IV DMFs for Excipients Using IPEC Guidance

Ethylene Oxide in Pharmaceuticals and Consumer products – Essential Intermediate, High-Risk Exposure – A Regulatory Deep Dive

How to Address Data Consistency Challenges in EU MDR Submissions: A CAPTIS® Perspective

From Supplier to Label: Mastering Allergen Statements in Drugs and Cosmetics

A Strategic Guide to PMS, eAF, ePI, eCTD 4.0. and ESMP

Devices Incorporating Tissues or Cells of Animal or Human Origin, or Their Derivatives: Data Expectations Under EU MDR

Nitrosamine Control Insights: Clarity and Control in EU Risk Assessment