• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

BioStartup Advice

  • Simulations
        • A Day in a Life: Exploring the biostartup possibility
        • Steps to a Startup
  • Read More
        • Read More:


        • Women Life Scientists as Entrepreneurs
        • Communication Skills for Women Scientists
        • Contemplating Entrepreneurship
        • Early Funding
        • Starting a Life Science Business
        • Basics of Intellectual Property
  • About
    • About BioStartup
    • About Us
    • Contact
  • Self-Check
  • Resources
    • Resources
    • Glossary
    • Blog
          • Topics:

          • Category:

          • Sort By:

          • Clear Filter
        • Resources | Tips | Case Examples
Home › Topics › Starting a Life Science Business › Registering Your Business

Industry-Specific Requirements, Licenses, and Permits

Topics Starting a Life Science Business Registering Your Business Industry-Specific Requirements, Licenses, and Permits

Unique Requirements for Biotech and Medtech Ventures

  1. Biotechnology products often require regulatory approval, e.g., Food and Drug Administration (FDA) approval.
    • The FDA regulates medical devices, radiological health, over-the-counter drugs, prescription drugs, biological therapeutics, and biological products, including certain human cells and tissue products, medical test kits, and drug products (Registrar, 2023). Obtaining FDA approval for your product is an important hurdle to clear before a successful product launch. Safety, efficacy, and manufacturing controls are needed for FDA approval. You may need to modify the product in response to obtaining regulatory approval.
  2. If yours is a biomedical product, make sure that health insurance will pay for the use of the product or the medical procedure for which it will be used (ULP, 2022).

References

Registrar Corp. How to Get FDA Approval. Registrar. 2023.

University Lab Partners. Reimbursement for MedTech and Biotech Startups. October 17, 2022.

Resources

US Food and Drug Administration – Official website.

FDA Resources – NCI SBIR Development Center.

How to Get FDA Approval – Registrar Corp. 2021.

FDA Review and Approval – A toolkit provided by NCATS.

CARE Regulatory Program – A support offered by NCI for communication between small businesses and regulatory experts at the FDA.

3 Key Medical Device Reimbursement Challenges Manufacturers Face Globally – Infiniti Research.

Breaking the Myths of Medical Device Reimbursement – MediClever Reimbursement Consultants.

Health Insurance Coverage and Reimbursement Decisions – Issue Brief. American Academy of Actuaries. 2008.

FDA Small Business Assistance – Includes the. . .

  • Center for Biologics Evaluation and Research (CBER)
  • Center for Drug Evaluation and Research (CDER)
  • Office of Regulatory Affairs (ORA) district offices and small business representatives

Licenses and Permits

Depending on the nature of your business and location, you may need various federal and state licenses and permits for your small business (SBA, 2023). Become aware of the fees and waiting periods involved. Keep track of expiration and renewal dates. Here are two examples:

  • Sellers permit – If you sell tangible items to the public, you may need this permit from your state.
  • If a federal agency regulates your business activities, you need a permit or license. For example, in agriculture, if you import or transport animals, animal products, biologics, biotechnology—including genetically engineered organisms—or plants across state lines, check with the US Department of Agriculture. The SBA resource, “Apply for licenses and permits,” describes many of these licenses and permits unique to each industry.

Reference

SBA. Apply for licenses and permits. Apply for licenses and permits.

Resources on Licenses and Permits

Apply for licenses and permits – Small Business Administration resource that describes federal licenses and permits organized by business activity and advises how to find information on state licenses and permits.

The Small Business Administration (SBA) website is a good place to start when founding a business. These two pages may be particularly helpful:

  • The Essential Guide to Starting a Business
  • Find local assistance
Previous Article
Back to Sub-Topic
Next Sub-Topic

Primary Sidebar

Topic Home Expand All
Intro to Starting a Life Science Business
3 Articles
Overview of Starting a Life Sciences Business
Evaluate Your Business Skills
Finding a Sound Business Idea
Early Market Research
3 Articles
Case Example: Leslie Bowen, Early Market Research
Market Research Before Starting a Business
Tips for Biomedical Market Research
Business Planning & Commercialization
9 Articles
Writing a Business Plan
Develop a Reimbursement Strategy
Technical and Business Assistance and Other Commercialization Support
Case Example: Commercialization Advice
Other Post-SBIR Commercialization Support
Planning Your Research Environment
Technology Readiness Level
Design, Prototype, Testing, Manufacturing
Tips on Planning from Successful Biotech Entrepreneurs
Financial Skills, Planning, & Investors
6 Articles
Financial Planning
Tackling Financial Risk
Equity and Shares
Sources of Capital for Small Businesses
Case Example: Learning Investor Basics
Entrepreneur Financial Skills and Resources
Registering Your Business
3 Articles
Business Name, Tax IDs, and Insurance
Registrations for Your Business
Industry-Specific Requirements, Licenses, and Permits
Your Business Governance
4 Articles
Select a Business Structure
Cofounders, Partners, and Founding Team
Board of Directors
Roles You Can Play in the Business
Return to Starting a Life Science Business
End Resources

This project is funded by National Institute of General Medical Sciences (Grants 1R43 GM131458-01 & 2R GM131458-02)


  • Contact
  • Copyright & Reproduction Guidelines
  • Privacy Policy
  • Terms of Service
  • Technology Requirements
  • 508 Compliance

Footer

a product of
Health Impact Studio
a division of Clinical Tools, Inc
  • Simulations
  • Contact
  • About
  • Blog
  • Facebook
  • LinkedIn
  • Twitter
feedback@clinicaltools.com

101 A Market St Chapel Hill, NC 27516
919-960-8118

We're Hiring!

Join the Development Team!

© 2023 · Clinical Tools, Inc · Log in

Forgot Password?
Register New Account
Sign up for our Newsletter!

  • Hidden

Register

"*" indicates required fields

Name*
Consent

Login
Accessing this topic requires a login. Please enter your credentials below!

Lost Your Password?
Register
Don't have an account? Register one!
Register an Account

Registration confirmation will be emailed to you.