Clinical Study Start-Up & Regulatory Site Activation
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Regulatory affairs IPR & Patents
Global Institute of Health Science is a pioneer in health science education, especially in distance and online learning. The institute is ISO 21001:2018 certified and globally acclaimed, with copyright approval from IPR Government of India and international certification from UASL UK for Quality Control Management Systems.
The GIHS Advantage
- Bringing Excellence to Health Professionals
- 15+ Years of Experience with International Exposure
- Internationally Acclaimed with ISO & Government Approval
- Lifetime Free Personalized Tutoring for Student Success
Regulatory affairs (RA), also called government affairs, are a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory affairs also have a very specific meaning within the healthcare industries globally and professionals can be recruited in Pharma companies, medical devices, biotech, biologics and functional food areas. It deals with government or law. Global regulatory agencies are as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA). This Program is developed to prepare professionals for regulatory affairs positions in the pharmaceutical, biopharmaceutical and medical device industries i.e. to facilitate them with the educational foundation that will support them advance in the regulatory affairs profession. The program will provide the students with the fundamentals required in both regulatory affairs and quality operations.
Syllabus
Clinical Data Management
Career Options
Fees, Payment & Program Duration
Certificate Program
- Duration : 3 Months
- Foundation-level program
- Industry awareness focus
- Expert-designed syllabus
- Research-based curriculum
- Academic & tech support
- Skill development course
- Global accreditation & Govt-recognized
₹22,999
- Indian candidates
- $450* USD For International Candidates
Post Graduate Diploma Program
- Duration : 1 Year
- Advanced-level professional course
- Research-based modules
- Lifetime expert support
- Job & career assistance
- Free Career Boost (www.TopCVCoach.com)
- High employment potential
- Global accreditation & Govt-recognized
₹32,999
- Indian candidates
- $699* USD For International Candidates
*Fees subject to taxes & exchange rates.
Fast Track PG Diploma Program
- Duration : 4 Months
- Accelerated PG-level program
- Flexible learning format
- Lifetime expert support
- Research-driven curriculum
- Free Career Boost (www.TopCVCoach.com)
- Job-oriented training
- Global accreditation & Govt-recognized
₹36,999
- Indian candidates
- $750* USD For International Candidates
*Fees subject to taxes & exchange rates.
- Disclaimer: This course details are for the purpose of awareness about the program and career opportunities. The exact information on course structure may vary from this information.
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Frequently Asked Questions
It is the profession that helps organisations understand and meet the regulatory requirements that apply to products
and activities in regulated industries such as pharmaceuticals, biotechnology and medical devices.
Yes — IPR and patents, together with trademarks, copyrights and related regulatory and legal concepts.
Yes. USFDA, ICH guidelines, European Union authorities with reference to EMA and UK MHRA, WHO guidelines and Rest of
World markets are all in the syllabus.
Yes. The Common Technical Document and submission of the Drug Master File to USFDA are both included.
Yes — medical device registration in India, regulation of devices and cosmetics, generic products, and biosimilars in
India and Europe.
No. Patent-agent and attorney status is governed by jurisdiction-specific legal and professional requirements. The
programme builds professional IPR and patent knowledge but does not replace statutory registration.
No. AI can support drafting and review, but submission content must be accurate, traceable, reviewed and compliant —
and the accountable decision stays with a qualified professional.
Yes. The online and distance-learning format suits eligible working professionals seeking regulatory, quality, compliance
or IPR upskilling, with a Fast-Track option available.
Course material with the latest updates, online access within 48 hours, printed books shipped with your enrolment, a
personal subject expert for life at no cost, the online examination and project assessment, and two international
certificates on successful completion. There are no hidden charges.
Yes. Every GIHS enrolment now includes complimentary TopCV Coach access worth ₹9,999 for professional resume
building and interview skills, and your profile is posted on the TopCV website where a large recruiter network is active.
Yes, within your lawful professional scope. The Business & Entrepreneurship section of this brochure sets out the nonclinical services, education and consulting work the knowledge supports. Regulated clinical services require the
appropriate qualification and authorisation.
Yes. Any graduate from any discipline may enrol, as can working professionals with relevant experience, entrepreneurs
and managers of healthcare or allied organisations.
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