CTD (Common Technical Document) is a standardised format used to organise the quality, nonclinical, clinical, and administrative information required for drug approval. eCTD (electronic Common Technical Document) is the electronic version of the CTD. It allows regulatory documents to be submitted, reviewed, and managed digitally throughout a product’s lifecycle. Role in Regulatory Affairs The role of regulatory affairs in drug development includes preparing regulatory submissions, ensuring compliance, and coordinating with health authorities. CTD and eCTD are therefore important for efficient regulatory affairs and drug development processes. Molkem supports the pharmaceutical sector with a focus on quality, compliance, and structured processes. Conclusion CTD provides the structure, while eCTD provides the electronic submission format. Both are essential for organised and compliant regulatory submissions.