Regulatory Affairs for Pharmaceutical Industry
Researium Labs, Karnataka presents an online hands-on training program designed to provide practical exposure to pharmaceutical regulatory affairs, drug development regulations, approval pathways and compliance requirements.
Training dates
Online via Google Meet
Registration fee
Research scholars/PhD, faculty, industry professionals and others
About the Training
This one-month hands-on Regulatory Affairs training is described in the supplied notice as an intensive program for pharmaceutical, life science and biotechnology students.
It covers global regulatory frameworks, dossier preparation, CTD/eCTD structure, GMP documentation, clinical-trial submissions and post-marketing regulatory activities.
The stated objective is to provide practical skills relevant to regulatory roles in the pharmaceutical industry.
Key Training Highlights
- IND — Investigational New Drug application
- NDA — New Drug Application dossier
- ANDA — Abbreviated New Drug Application
- CTD/eCTD — Common Technical Document / electronic CTD
- USFDA Orange Book & Purple Book
- NLEM compliance
- SOPs and clinical trial protocols/reports
- Adverse Drug Reaction (ADR) forms
- Regulatory submissions for FDA, EMA, CDSCO, MHRA and WHO
- Product labelling and packaging documents
- eCTD submission software
- RIMS and DMS
- CTMS and Pharmacovigilance databases
- Quality Management Software (QMS)
- Labelling management software
- Technical writing tools for regulatory documents
Registration Details
Registration Fees
Register for the Training
Use the registration link provided in the supplied training notice.
REGISTER ONLINERegistration link reproduced from the supplied source. Check the organizer’s latest communication before making payment or submitting personal information.
Organizer & Contact
Organizer: Researium Labs, Karnataka
Email: researiumlabs@gmail.com
Quick Summary
Training: Regulatory Affairs for Pharmaceutical Industry
Duration: 5 October – 3 November 2026
Time: 8:00 PM – 9:00 PM
Mode: Online via Google Meet
Fee: ₹500 for UG/PG students; ₹700 for the other categories listed in the notice
Registration deadline: 4 October 2026

