Advanced Post Graduate Diploma in Regulatory Affairs (Formulation)
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Last updated on 18 Dec 2025
Overview
An Advanced Post Graduate Diploma in Regulatory Affairs, focusing on formulation under the specialty of Drug Regulatory Affairs, is a comprehensive educational program designed for professionals working in the pharmaceutical industry. The duration of the program is generally 1 year but it may vary depending on the institute offering the program. The curriculum includes topics like biochemistry, biological aspects of regulatory documentation, clinical trials, health care policies, etc.
Table of Content
What is a Advanced Post Graduate Diploma in Regulatory Affairs (Formulation)?
The Advanced Post Graduate Diploma in Regulatory Affairs (Formulation) focuses on the regulatory frameworks governing drug formulation. It provides insights into national and international drug approval processes, pharmaceutical compliance, and safety regulations.
Highlights:
| Particulars | Advanced Post Graduate Diploma in Regulatory Affairs (Formulation) |
| Course Type | Post Graduate Diploma |
| Duration | 1 Year (Varies by Institute) |
| Eligibility | Graduates in Pharmacy, Life Sciences, Biotechnology, or related fields |
| Admission Process | Merit-Based / Entrance Exam |
| Fees | 35,400 |
| Colleges in India | IPM, Pune |
| Job Roles | Regulatory Affairs Specialist, Compliance Manager, Drug Safety Officer, Quality Assurance Executive |
Eligibility:
The Advanced Post Graduate Diploma in Regulatory Affairs Eligibility requires candidates to have a Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or related fields. Some universities may require prior work experience in the pharmaceutical sector
Duration:
The Advanced Post Graduate Diploma in Regulatory Affairs (Formulation) is typically 1 year, but some universities in India may offer variations in course duration.
Fees:
The Advanced Post Graduate Diploma in Regulatory Affairs Fees is 35,400rs . Factors such as course delivery mode (online or offline) and university reputation influence the cost.
Who Should Do This Course?
- Experts working in the fields of pharmaceuticals, biotechnology, and healthcare.
- Graduates looking for regulatory affairs jobs in India and abroad.
- Individuals interested in pharmaceutical policy, documentation, and clinical trials.
Why Study This Course?
- Gain expertise in regulatory documentation, compliance, and safety protocols.
- Learn about global regulatory agencies such as FDA, EMA, CDSCO, MHRA, and TGA.
- Expand career opportunities in pharmaceutical regulatory affairs jobs.
Entrance Exam:
Some institutes require students to pass an entrance exam for admission to the Advanced Post Graduate Diploma in Regulatory Affairs (Formulation) program
Admission Process:
The admission process varies by university and includes:
- Filling out the application form (Online/Offline).
- Entrance Test or Direct Admission based on eligibility.
- Interview (if applicable).
- Final Selection and Fee Payment.
Syllabus:
| Year/Semester | Courses |
| Semester 1 | Biochemistry, Drug Regulatory Frameworks, Clinical Research Guidelines |
| Semester 2 | Global Pharmaceutical Laws, Regulatory Documentation, Drug Approval Process |
Top Colleges:
The Advanced Post Graduate Diploma in Regulatory Affairs University options include:
- Institute of Pharmaceutical Management (IPM)
Scope:
The Advanced Post Graduate Diploma in Regulatory Affairs in India offers vast career opportunities in pharmaceutical regulatory affairs, quality assurance, drug safety, and clinical research. Graduates can work in pharmaceutical companies, biotech firms, regulatory agencies, and contract research organizations (CROs).
Further Study Options:
After completing this diploma, candidates can pursue:
- Advanced Certifications in Regulatory Affairs
- MBA in Pharmaceutical Management
- Higher Studies (M.Pharm, MS in Regulatory Science, etc.)
Career Opportunities After This Course:
- Regulatory Affairs Officer
- Pharmaceutical Compliance Manager
- Drug Safety Specialist
- Quality Assurance Executive
- Clinical Research Associate
Salary:
The salary for professionals in Regulatory Affairs depends on experience:
| Experience Level | Average Salary (INR per annum) |
| Entry Level | ₹3,00,000 - ₹5,00,000 |
| Mid-Level | ₹6,00,000 - 8,00,000 |
| Senior Level | ₹8,00,000+ |
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FAQS
What is advanced post graduate diploma in Regulatory Affairs (API & formulation)?
It is a specialized diploma focusing on Active Pharmaceutical Ingredients (API) and drug formulation regulations. The program includes pharmaceutical compliance, documentation, and safety standards.
Who should enroll in this program?
- Graduates in Pharmacy, Life Sciences, Biotechnology.
- Professionals working in regulatory affairs, compliance, or clinical research.
What is the focus of drug formulation in regulatory affairs?
- Ensuring that pharmaceutical formulations meet safety, efficacy, and quality standards.
- Understanding the regulatory guidelines for drug manufacturing and approval
What is the duration of the program?
The Advanced Post Graduate Diploma in Regulatory Affairs (Formulation) is typically 1 year, though some universities in India may have variations.
What certifications can I pursue after completing the diploma?
Graduates can enhance their credentials by pursuing:
- Regulatory Affairs Certification (RAC)
- ICH-GCP Certification
- GMP Compliance Training
Related Course titles
Qualifications
BSc Chemistry
BPharm (Bachelor Of Pharmacy)
BSc Life Sciences
BSc Biotechnology
Related Specialty
Drug Regulatory Affairs