White Paper Series

Developing drugs and radiopharmaceuticals is no longer only about strong non-clinical and clinical data. A well-designed regulatory strategy has become a decisive success factor for regulatory approval, time-to-market, and long-term commercial viability.

Why it matters now

Radiopharma’s unique environment raises the stakes significantly. The EMA has recently launched a public consultation on a dedicated guideline for radiopharmaceuticals — confirming increased scrutiny on CMC and GMP implementation. Teams need to anticipate these requirements to avoid costly redevelopment and delayed submissions.

How can Trasis support your CMC and regulatory journey?

As a CDMO specialized in GMP manufacturing of API precursors, raw-material kits, and sterile radiopharmaceutical drug products, Trasis combines radiochemistry, process development, automation, and regulatory expertise to help you design and execute end-to-end regulatories strategies that are phase-appropriate, globally aligned, and scalable.

Discover Trasis end-to-end approach

What’s inside: a three-part white paper series

To help you navigate this complexity, Trasis has developed a practical, end-to-end series, released sequentially:

White Paper 1

Foundational CMC concepts

Core CMC principles, regulatory vs. manufacturing quality, Module 3 structure, and lifecycle evolution of requirements.

White Paper 2

Ready-for-use radiopharmaceuticals

Regulatory strategy for PET tracers and therapeutic radiopharmaceuticals, purification choices, excipients, and Module 3 options.

White Paper 3

Kits for radiopharmaceutical preparation

Quality strategy for dual drug product status, microdose aseptic filling, and site responsibilities.

Each paper includes: decision trees, ready-to-use checklists, and practical frameworks you can directly apply in regulatory discussions, governance meetings, and partner interactions.

Who should read this?

This series is designed for CMC, Regulatory Affairs, quality and manufacturing leaders, as well as executives and nuclear medicine teams navigating complex radiopharmaceutical programs.

Get your complimentary access

Leave your details to receive the full three-part series step by step, with practical tools and the option to connect with Trasis experts on your specific challenges.

How to build a winning regulatory strategy in radiopharmaceutical development?