Regulatory Writing Course Training Certification- Henry Harvin®

Regulatory Writing Course

Henry Harvin® Ranks in Top 30 most Trusted Companies by Insight Success

  • ★ ★ ★ ★ ★ 4.9/5 Ratings
  • 1.1 Million Learners
  • 3271 Learner’s Rating
  • 81% Report Career Benefits

Learn Regulatory Writing with Henry Harvin® I We provide Globally accepted Certification, Real-time projects, 24*7 Free Tenant Access & much more I This training provides the Most Extensive Collection of Resources Available on Global Regulations I Learn with experts a possibility to learn strategies, tricks, action plans to become a confident Regulatory Writer

Starts In 2 day

26 Feb 2024

EMI Starting at

₹ 8778/month

Total Program Fee

₹ 79000

Learning Period

96 Hours

Placed Learners

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Accreditations & Affiliations

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World’s #1 Upskilling & Reskilling Institute

Key Features

9-in-1 Benefits

Training + Projects + Internship + Certification + Placement + E-learning + Masterclass + Hackathons + Gold Membership

Industry-Acclaimed Curriculum

The curriculum is designed in a structured & coherent manner by our qualified experts to meet  the requirements of the learners.

Real-Time Projects & Assignments

At the end of the course, each learner gets hands-on experience by working on projects & assignments.

Learn From Industry Experts

Get trained directly from the domain specific industry experts to polish your existing knowledge and skills.

24x7 Learner Assistance and Support

Full time access and support to resolve your technical queries and doubts. Get Free access to E-learning Portal and future updates.

1 Year Gold Membership

Once enrolled at our Writing Academy, attend different batches with different trainers during membership period without paying extra.

Upcoming Cohorts

Our Placement Stats

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Average salary hike


Access the best jobs in industry

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Maximum salary hike

About the Regulatory Writing Course

What is Regulatory Writing?

Developing preclinical and clinical research procedures into documents and submission packets that review and record key study conduct, practices, and results is known as regulatory writing.

The creation of regulatory documents is the responsibility of a regulatory writer. These documents should follow the pertinent guidelines and be suitable for their intended use, which requires that they convey the necessary information to the intended audience in an accurate, open, and understandable manner.

Job Roles Offered:

  • Regulatory Writer
  • IVD Writer
  • Medical Writer
  • Expert Regulatory Writer
  • Senior Writers - Clinical Trials

9 in 1 Course

  • Training: 96 Hours of Two-Way Live Online Interactive Sessions
  • Projects: Facility to undergo projects in ICH Guidelines, IND & NDA Requirements & more
  • Internship: Get Internship Support to gain experiential learning
  • Certification: Get a Digital Badge of Certified Regulatory Writer (CRW) from Henry Harvin® Govt of India recognized & Award-Winning Institute, and showcase expertise
  • Placement: 100% Placement Support for 1-Year post successful completion of the course
  • E-Learning: Free access to E-learning Portal and future updates
  • Masterclass: Access to 52+ Masterclass Sessions for essential soft skill development
  • Hackathons: Free Access to #AskHenry Hackathons and Competitions
  • Membership: 1-Year Gold Membership of Henry Harvin® Writing Academy for the Regulatory Writing Course

Trainers at Henry Harvin® 

  • Most respected industry experts with 15+ years of working experience and recognized by numerous organizations over the years for their work
  • They have delivered 400+ keynote classes for the Regulatory Writing Course
  • Have delivered 450+ lectures and are currently empaneled as domain experts with Henry Harvin® Writing Academy

Alumni Status 

Become a part of the Elite Writing Academy of Henry Harvin® and join the 3,00,000+ large Alumni Network Worldwide.

Gold Membership Benefits 

  • Avail 1-Year Gold Membership of Henry Harvin® Writing Academy that includes E-Learning Access through recorded Videos, Games, Projects, CPDSPe Studies.
  • Access to Masterclass Sessions.
  • Earn the Prestigious Henry Harvin®️ Alumni Status and become one of the reputed 3,00,000+ Alumni across the globe.
  • Guaranteed Internship with Henry Harvin®️ or partner firms.
  • Weekly 10+ job opportunities offered.
  • Experience Industry Projects during the training.

Learning benefits 

  • Flexible learning environments for Participants
  • Learn from the latest Industry trend Curriculum
  • Earn globally recognized Certification
  • Access to Assessments, Mock Tests and Case Studies
  • Get real-world Tips and Time-Tested Techniques from accredited Expert Practitioners
  • Understand the basic aspects of Overview of Regulatory, Marketing & Drug Promotion Process
  • Learn in-depth about ICH Guidelines
  • Learn to work with Clinical Study Reports
  • Learn types of Protocols & Investigator’s Brochures
  • Get plenty of Job Opportunities in India & Abroad

Know the complete offerings of our Regulatory Writing Course

You Get 10-In-1 Program

Two-way Live Training Course


Hallmark Certification


10+ Projects


Guaranteed Internship


Personalized Job Support


Student Engagement & Events




E-Learning Access


Gold Membership


Entrepreneurship Mentorship


Regulatory Writing Course Curriculum

  • Module 1: Introduction to Drug & Cosmetic Act

    • Introduction, Aims and Objectives, Definitions
    • Schedules to Drug Rules
    • Import, Manufacture and Sale of Drugs
    • Labeling and Packaging of Drugs
  • Module 2: Schedule Y

    • Introduction, Amendments to Schedule Y
    • Clinical Trials
    • Studies in Special Population, Post Marketing Surveillance and Special Studies
    • Appendices
  • Module 3: Indian Regulations Governing Clinical Trials

    • Regulatory Authorities in India
    • Guidelines and important provisions
    • Indian Regulatory Approval Process and approval timelines
  • Module 4: Common Technical Document

    • Introduction and overview of CTD and eCTD
    • Putting it all together – CTD Module 1
    • Putting it all together – Producing the CTD Modules
    • Multi-region submissions & submission standards
    • Interfacing with regulatory agencies and answering queries
    • Aggregate safety reports
  • Module 5: Regulatory Regime in US

    • Responsibilities of US FDA
    • FDA Centers
    • Code of Federal Regulations
    • FDA guidelines for industry
  • Module 6: European Medicine Agency (EMEA)

    • Introduction, Roles and Responsibilities of EMEA
    • Committees of EMEA
    • EU Clinical Directives
    • EUDRA CT
  • Module 7: Overview of Regulatory, Marketing & Drug Promotion Process

    • Introduction to Regulatory Medical Writing
    • Investigation New Drug & Investigational Device Exemption Application
    • Protocols, Amendments & Study Reports
    • Investigator Brochure & Product Labels
    • NDA’s, BLA’s & PMA’s
    • Annual Reports
    • Product Labeling
    • Abstracts & Posters for Scientific Meetings
    • Manuscripts for Publication in Scientific Journals
    • Legal-Copyright-IP Issues in Medical writing
  • Module 8: ICH Guidelines

    • ICH Safety Guidelines related to Carcinogenicity, Genotoxicity, Reprotoxicity
    • ICH safety guidelines related to pharmacology and immunotoxicology studies
  • Module 9: IND & NDA Requirements

    • IND and NDA applications in U.S
    • IND and NDA Applications in India
  • Module 10: Clinical Study Reports

    • Parts of a Clinical Study Report
    • Templates & Boilerplate Text
    • Tips on writing each section of the CSR
  • Module 11: Protocol, Investigator’s Brochure & Case Report Forms

    • Writing clinical study protocols
    • Introduction to writing Investigator Brochure
    • Writing case report forms
    • Writing regulatory compliant informed consent forms
    • ICSR – Patient Narratives

Know the complete offerings of our Post Graduate Program in Regulatory Writing Course

Skills Covered

Safety Guidelines

Regulatory Medical Writing

Product Labeling

Technical Documentation

Safety Reporting

Drug Promotion Process

Career Services By Henry Harvin®

Career Services

Placement Drives

We are dedicated to supporting our students throughout their career journey. Join us, and let's embark on a journey towards a successful and fulfilling career together.


Premium access to Henry Harvin® Job portal

Exclusive access to our dedicated job portal and apply for jobs. More than 2100+ hiring partners’ including top start–ups and product companies hiring our learners. Mentored support on job search and relevant jobs for your career growth.


Personalized Job Consulting

Share what kind of job you are looking for and we will provide you with verified job openings that match your requirement.

Get Ahead with Henry Harvin® Regulatory Writing Course Certification

  • Earn your Certificate

    Post-successful completion of the course, earn Henry Harvin® Certification of Regulatory Writing Course

  • Differentiate yourself with a Henry Harvin® Certification

    The practical knowledge and actionable skillset you've gained working on projects, simulations, case studies will set you ahead of the competition

  • Share your Achievement

    Talk about it on LinkedIn, WhatsApp, Instagram, Facebook, Twitter, boost your resume or frame it - tell your friends and colleagues about it

  • Training Certification

    Get a Digital Badge of Certified Regulatory Writer (CRW) from Henry Harvin®


Our courses and Course Certificates are trusted by these industry leaders


Know more about the value of this certificate in the industry

Regulatory Writing Course Training Certification Process

Counselling & Registration

Consult with our counselors to check your eligibility and the right batch, and then Register for the Regulatory Writing Course

Complete the Program

Attend 96 hour sessions and gain credits to get course completion certification from Henry Harvin® Writing Academy

Deliver Projects Assigned

Gather experience with real-world assignments and practical projects to upgrade your existing skills. Deliver these mini-projects to be eligible for the Henry Harvin® Course

Earn Certification

Post-successful completion of the course, earn Henry Harvin® Digital Badge of CRW. Post it on social media, get it framed, and increase your value in the industry

Know more about the value of this certificate in the industry

There's a reason that 95% of our customers undertake 3+ courses as a minimum with Henry Harvin®

Know the complete offerings of our Regulatory Writing Course


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Henry Harvin®️ ranks amongst the Top 500 Global Edtech Companies with 4,60,000+ Alumni, 900+ B2B Clients, 500+ Award Winning Trainers, and 1200+ Courses.




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Why Us?

Certified & Experienced Instructors

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Gold Membership & Post Training Followups

Tailor Made Training

Flexible Schedule

Access to the Recorded Sessions

10 in 1 Program

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