Regulatory Affairs Course in Hyderabad
CTD and eCTD, dossier preparation, labelling compliance, CDSCO and FDA overview.
Programme at a glance
- 6 topics in the curriculum
- Prepares you for 1 role
- Certificate of Completion
- At our Hyderabad centre or on your college campus
About the Regulatory Affairs programme
No medicine can be sold until a regulator approves it, and regulatory affairs is the team that prepares and submits that case. The work is to assemble the evidence on quality, safety and efficacy into the format each authority requires.
This course introduces the common technical document, the Indian and US regulators, and the practical task of compiling a dossier.
What you will learn
The topics the Regulatory Affairs curriculum covers.
- 01The role of regulatory affairs across a product's life
- 02CTD structure and what belongs in each module
- 03eCTD: the electronic format and how submissions are organised
- 04Dossier preparation and compilation
- 05Labelling compliance
- 06An overview of CDSCO and US FDA requirements
Choose a Regulatory Affairs batch length
All three formats are classroom-taught, at our Hyderabad centre or on your college campus in Telangana and Andhra Pradesh.
Short-term
6 weeks
2–3 hours a day
A focused introduction to one domain while you finish your degree.
Medium-term
3 months
3–4 hours a day
Covers a domain end to end with assignments and case studies.
Long-term
6 months
4–5 hours a day
The full programme, with projects and hospital or clinical exposure where applicable.
How you are taught
Classroom sessions
Trainer-led classes that build the theory each task depends on.
Case study discussions
Real scenarios worked through as a group, the way a team would at work.
Practical demonstrations
You watch a task done properly, then do it yourself.
Skill-based assignments
Regular exercises on the tasks a trainee is given in the first months of a job.
Industry-oriented projects
A longer piece of work that mirrors a real deliverable.
Hospital and clinical exposure
Time in a clinical setting, where the domain calls for it.
How you earn the certificate
You receive a Certificate of Completion in Clinical and Industry-Oriented Pharmacy Training once you complete the programme and pass each assessment.
Who can join
- D.Pharm
- B.Pharm
- M.Pharm (all specialisations)
- Pharm.D
- Pharm.D (Post Baccalaureate)
- 1Weekly quizzes
- 2Practical assignments
- 3Case study presentations
- 4Final evaluation test
- 5Viva (oral examination)
Regulatory Affairs questions
What does a regulatory affairs executive do?
They prepare and compile the documents a company submits to regulators such as CDSCO and the US FDA to get a medicine approved and keep it on the market.
What does the regulatory affairs course cover?
CTD and eCTD, dossier preparation, labelling compliance, and an overview of CDSCO and FDA requirements.
Who should take this course?
B.Pharm, M.Pharm and Pharm.D students who enjoy precise writing and want a desk-based role in the pharmaceutical industry.
Other pharmacy programs
- PharmacovigilanceDrug safety: adverse event reporting, MedDRA coding, narrative writing and case processing.
- Clinical ResearchICH-GCP, clinical trial phases, CRF handling and informed consent.
- Medical CodingICD-10, CPT and HCPCS overview, anatomy and medical terminology.
- Quality ControlSOPs, HPLC and GC basics, wet lab analysis and documentation.
- Quality AssuranceGMP, documentation systems, deviation management and CAPA.
- Hospital and Clinical PharmacyPrescription analysis, patient counselling and identifying drug interactions.
- Clinical SASSAS programming for clinical trial data: datasets, tables, listings and CDISC standards.
Start the Regulatory Affairs programme
Send us your details and we will call you to talk through the course, batch timings and fees. Or call us now.