CMC writing excellence:
From development to CTD content

• CMC writing conventions
• Pharmaceutical development
• Description of the manufacturing process and of analytical procedures
• GMP aspects and CMC content
• The quality part of the IND/IMPD along pre-/clinical development
• Working with service providers and compilation of the CTD

Who should attend

Our comprehensive training program equips you with practical tools and expertise to confidently prepare CMC documents for CTD submission, with a strong focus on language, structure, and concept.

Following an introduction to general conventions in CMC writing our experts will guide you through considerations for creating the development plan, including specific aspects for different dosage forms: solid, liquid and sterile products.
You will learn how to compile the description of the manufacturing process correctly and receive best practices for working with service providers. You'll also gain valuable insights into the creation of CTD submissions, benefiting from real-world examples and extensive regulatory experience.

Upon completion of this seminar, you will be able to present your data clearly and in full compliance with regulatory standards, ensuring consistency and logical flow that facilitates regulatory review and approval.

After having participated in the compact course, you as "advanced" CMC writer will have learned how to

• create the development plan;
• how to compile the description of the manufacturing process;
• how to work with service providers;
• how to handle the quality part of the IND/IMPD;
• how to create CTD-submissions.