Regulatory Submissions Training

Regulatory submissions training — CTD / e-CTD format, dossier modules, IND / NDA / ANDA workflows, and CDSCO / FDA / EMA submission expectations.

What is Regulatory Submissions Training?

This programme walks you through how regulated products are actually submitted for approval. From dossier structure to submission-portal mechanics, you learn the formats and expectations regulators around the world use to decide what reaches the market.

What you will learn

CTD / e-CTD module structure (Modules 1–5) and what goes where
IND, NDA, ANDA, BLA — when each applies and how they differ
CDSCO Indian regulatory pathway — overview and current expectations
FDA and EMA expectations at a working level
Drafting and review of representative dossier sections
Query / deficiency-letter response preparation

Who this is for

Students and early-career professionals from pharmacy, life sciences, biotechnology, chemistry, and clinical research targeting regulatory affairs roles in pharma, biotech, devices, or CROs.

What you take away

NTHRYS training certificate detailing regulatory submissions scope
A capstone — drafted dossier sections in CTD format
A working understanding of the most common regulatory pathways
A precise profile for regulatory affairs careers

Pick the field below to see specific regulatory training options.

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