Regulatory Writing

in the United States

Finally! An Accessible and
Comprehensive Online Course
on Regulatory Writing.


Regulatory writers are the best-paid professionals in the Medical Writing Industry. In fact, many of them earn six-figures. Look at these data from the American Medical Writers Association 2007 Salary Survey:


Mean Income by primary Employer

Biotechnology company: $102,297
Pharmaceutical: $97,807
Medical device company: $85,451



With new drug, devices, and treatments being developed every day, pharmaceutical, biotech, medical devices companies, and Contract Research Organizations (CROs) are hiring knowledgeable writers who understand the regulatory process in the United States. You can even be a freelance regulatory writer if you wish (according to the AMWA survey, the mean gross income for the freelancers interviewed was $119,295).


As a regulatory writer you should have good knowledge of clinical study design and conduct; how to write protocols and how to read and interpret clinical data (summary tables and listings). You should also be aware of case report form design, good clinical practice (GCP) regulations and regulatory document guidelines such as the ICH.


With this online course you can learn the basics of regulatory writing without spending a fortune or leaving your house or office. The course was developed by a regulatory writer with almost 30 years of experience in the industry.


Complete this online course and
receive a Certificate!

Are you a clinical research professional who is charged with writing a clinical study protocol?

Or a medical writer looking for guidelines to use for writing an IND for a new drug?
If so, this course is for you.


In today's competitive job market, educational credentials are vital. Add a line to your resume and show potential employers and editors that you have what it takes to be an excellent regulatory writer!


This course is divided in two modules. While the first module (Introduction to Regulatory Writing) teaches the drug development and approval process in the United States, the second module (Clinical Trial Reporting) describes how to prepare regulatory documents.


Module I: Introduction to Regulatory Writing

  • How Medical Products are Classified: Distinction between Pharmaceutical Drugs, Biologics, Medical Devices, or Combination Products

  • FDA's Regulatory Divisions

  • Details Regarding Regulatory Planning, Documents Preparation, and FDA Submissions to Gain Market Approval of Drugs in the US

    A. The Drug Regulatory Process

    B. Details Regarding Preclinical Research

    C. Details Regarding INDs

    D. Conducting Human Clinical Trials

    E. The FDAs Regulation on Good Clinical Practice (GCP)

    F. Submitting a New Drug Application (NDA)

    G. Pre-launch Activities

    H. Launch Activities

    I. The Product Sales Cycle

  • FDA Regulation to Gain Market Approval of Biologics in the US

    A. What are Biologics?

    B. Biologics Clinical Trials Manufacturing

    C. Differences and Similarities between Biologics Development and New Drug Product Development Regulations

    D. Submitting a Biologics License Application for FDA Market Approval of a Biologic

  • FDA Regulation to Gain Market Approval of Medical Devices in the US

    A. The Medical Device Classification

    B. Premarket Notifications or 510(k)

    C. Premarket Approval Applications (PMAs)

    D. PMA Supplementation

    E. Humanitarian Device Exemptions (HDEs)

    F. Investigational Device Exemptions (IDEs)

    G. IDE Amendments

    H. Product Development Protocols (PDPs)

    I. Medical Device Code of Federal Regulations (CFRs)

    J. Steps to Obtaining Marketing Clearance from CDRH

    K. Other Requirements besides Marketing Clearance

Module II: Clinical Trial Reporting

Clinical trials have very stringent guidelines that must be followed. The same is true regarding the documentation required by the Food and Drug Administration. If these guidelines are not followed, then the entire regulatory approval may be delayed or jeopardized altogether.


Medical writers and clinical research professionals must understand the regulatory requirements for all regulatory reports that they are required to write during their careers.

This module distills the regulations regarding the most common regulatory documents into a single, user-friendly guide. This module will show you how to develop each of these documents:

• Pre Investigational New Drug (IND) Application
• Investigational New Drug (IND) Application
• Investigational New Drug (IND) Reports
• Informed Consent Form
• Investigator’s Brochure
• Clinical Reports
• Pre New Drug Application (Pre-NDA)
• New Drug Application (NDA)
• Patient Narratives
• Manuscripts

At the end of the course you will take a test to evaluate your understanding of the material and receive a certificate of completion.


What is your investment for this comprehensive course?


Many of the available workshops for regulatory writers are way too expensive—$1,950 or more for a couple of days, plus travel expenses.
(See here, for example.)


You can take this online course from the comfort of your home for only $257. Once your interactive test is completed and your instructor gets back to you, you will receive a Certificate in the mail at no extra cost.


Free Gift for Signing Up Today


A FREE copy of the ebook Becoming a Medical Writer: How to launch a successful career writing about medicine and health. A $29 value.

About the ebook >>


Yes, Sign Me Up for this Course!


Pay by credit card or your Paypal account. You have two payment options:


1. One single payment of $257.00.


2. Or two payments of $130.00, 30 days apart.


You will gain immediate access to your materials after payment. You will also receive a follow-up email with instructions on how to access the online course within 24 hours.


Money Back Guarantee

If for any reason, you are not satisfied with the course, just contact us within 8 weeks and we'll refund 100% of your money. And you can keep your free gift!


Note: Reimbursements will not be applied after your certificate has been sent.



Tax Deductible - Keep your receipt. In the USA, all expenses of continuing education undertaken to maintain and improve business and professional skills are tax deductible. (Treas. Reg. 1-162-5). Please contact your tax consultant for further information.


"This online training provided me with convenient and fundamental knowledge of the FDA's regulations for drugs and devices. I would recommend this course to anyone who needs background knowledge or is just starting out learning the regulations."


Dawn Pearson
Seattle, WA


What Regulatory Writers are Saying



“I've worked as a nurse (15 years), clinical research coordinator (5 years), consultant, writing SOPs for Pharma companies (2 years), then medical writing (7 years and counting). The latter is the best job I've ever had, as it draws on so many different parts of me. I was in the right place at the right time at so many points in my life. I could chalk it up to luck, but I also remind myself of Pasteur's observation: "Chance favors the prepared mind." If you are considering a career in medical writing, don't be afraid to take a risk. Try it, you might like it!”


Becky Hansen
Regulatory writer, MGI PHARMA
Bloomington, Minnesota



Two-Course Package: Enroll in two courses and save 20%


Regulatory Writing + Epidemiology & Biostatistics = $331


Regulatory Writing + Consumer Health Writing = $364