USFDA Regulatory Affairs

This course is ideal for:

• Regulatory Affairs Professionals looking to strengthen their expertise in USFDA compliance and submissions.
• Pharmaceutical & Biopharmaceutical Industry Professionals involved in drug development, clinical trials, or product registration.
• Medical Device & Biologics Experts seeking to understand USFDA regulatory pathways.
• Quality Assurance & Compliance Specialists focusing on U.S. market requirements.
• Pharma Entrepreneurs & Consultants who need to navigate the U.S. regulatory landscape.
• Students & Fresh Graduates aspiring for a career in regulatory affairs.

Course Features

The participant will be understanding about the US pharmaceutical and biopharmaceutical development to commercialization process in detail. Course is divided into two phases.

Phase 1 – US Pharmaceutical Regulatory Affairs

Phase 1 focuses on the detailed training on US regulatory approval of drugs (chemical small molecules). It covers stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications. Course covers fundamental to advance learning on drug development, regulation, registration and strategic management process.

Phase 2 – US Biopharmaceutical Regulatory Affairs

Phase 2 focuses on the detailed training on US regulatory approval of biopharmaceuticals. Further, the course is divided into innovator biologics regulation and biosimilar regulation. It covers  stages of biologic license application process and approval pathway, biosimilar development and approval pathway.  Course covers fundamentals to advance learning on biomanufacturing, process development, regulation, registration. Above all, the course is specialized on biologic strategic portfolio management. Moreover course covers US Biosimilar regulation, market access with patent dance and related process.

Other important features to note:

• Course provides orientation to job related practical aspects of the drug regulatory managers.
• Simulation to real life working in the regulatory affairs department. It helps to enhance the regulatory strategic decision making.
• Advance training on drug registration requirements for various regulatory bodies.
• Access to Case Studies to learn about the drug registration steps.

Benefits of the course

• Gain practical regulatory knowledge to handle USFDA submissions confidently.
• Enhance your career prospects with a globally recognized certification.
• Develop expertise in compliance, FDA inspections, and post-market regulatory requirements.
• Build a strong foundation in biologics, biosimilars, and medical device regulations.
• Become proficient in strategic regulatory planning for U.S. market entry.

Royed Training’s Executive Program in International Drug Regulatory Affairs (EPGIDRA) and Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course include comprehensive USFDA regulatory affairs training sessions. Additionally, we offer a dedicated USFDA ANDA filing training, which is part of our 1-week certification course in ANDA submission management.

Few of the similar courses

• Life Science Regulatory Affairs
• Medical Device Regulatory Affairs
• Drug Registration in China 
• Latam drug registration process
• Drug Registration and Regulation in UAE
• European Drug Regulatory Affairs
• GCC Drug Regulatory Affairs

Career in Drug Regulatory Affairs. How US regulatory affairs certification helps?

A career in Regulatory Affairs is very challenging, but highly rewarding. It opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. Regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance.

A career in Drug Regulatory Affairs (DRA) offers immense opportunities for professionals in the pharmaceutical and biopharmaceutical. Regulatory affairs professionals play a crucial role in ensuring that drugs, biologics, and medical devices comply with global regulatory standards, facilitating product approvals and market access. Among the different regulatory agencies worldwide, the U.S. Food and Drug Administration (USFDA) holds significant global influence.

The United States pharmaceutical and biopharmaceutical industry is growing rapidly. Since the U.S. operates as a highly regulated market, authorities frequently change or update pharma regulations and laws. Therefore, participants must continuously update their knowledge to stay informed and compliant.

Why your Expertise in U.S. Regulatory Pathways is critical for success in Regulatory Affairs?

The USFDA approval process is one of the most rigorous and involves multiple regulatory steps. Pharma, biotech companies actively seek professionals with deep expertise in these pathways.

A regulatory professional well-versed in U.S. pathways can:

• Guide companies through IND (Investigational New Drug) applications for clinical trials.
•  Prepare successful NDA (New Drug Application) or ANDA (Abbreviated New Drug Application) submissions.
• Ensure biologics approvals through BLA (Biologics License Application) processes.
• Navigate post-market regulatory compliance, labeling, and FDA inspections.

Without proper regulatory expertise, companies may face delays, rejections, or costly compliance issues, making skilled professionals indispensable.

USFDA Compliance Is a Gold Standard for Global Markets

Many international regulatory agencies, including EMA (Europe), TGA (Australia), Health Canada, PMDA (Japan), and emerging markets, align their regulations with USFDA standards.

Regulatory professionals with strong USFDA expertise are often preferred for global roles, as they bring knowledge of:

• Good Manufacturing Practices (GMP)
• Clinical Trial Regulations (IND, NDA, ANDA, BLA)
• Risk management and post-market surveillance

Thus, mastering U.S. regulatory pathways gives you an edge in international regulatory affairs and global product approvals.

One more important thing to note here. In recent times there is a rising concern over the safety and efficacy. US regulators even found to be busy auditing plants and lot of 483 observations and warning letters are issued across globe for manufacturing companies. Hence, course participant requires advance training on warning letter, 438 observations.

Lastly, “Data Integrity” is the latest buzz word. Lot of data integrity issues leads to 483s or even warning letters. In fact, more than 30
% of the warning letters are due to data integrity. Regulatory professionals should know what is data integrity and how to handle the data integrity issues.

Conclusion

In conclusion, this US regulatory certification course trains the candidate on not only on drug and biologic registration and regulation, it covers all important recent aspects. For example, course includes how to handle USFDA warning letter, 483 observations, data integrity issues, etc.