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About Us

Developed by OneSource Regulatory (OSR) is a solution called MyIndago. Our first product, called MyIndago Advertising and Promotion (A&P), is a solution that allows a user to search pharmaceutical and biotech U.S. Food & Drug Administration correspondence regarding advertising and promotion regulation. Our second solution, called MyIndago Health Authority Decisions (HAD), is a separate solution that allows users to easily search and compare FDA and EMA approval documents for thousands of approved drugs. Advanced Filter options with the FDA search enables the user to find additional categories such as Off-Patent, Off-Exclusivity Drugs without an Approved Generic and REMS products.

OneSource Regulatory (OSR) is the first full-service provider in our industry to offer innovative software and solutions for Regulatory, Medical and Compliance professionals. Utilizing expertise from decades of proven industry experience, OneSource provides the following unparalleled services:

  • Regulatory Affairs
    • Advertising & Promotion Review
    • Labeling development (TPP, CCDS, and local label development, including the US PI and the EU SPC)
    • Chemistry, Manufacturing & Controls (CMC)
    • Strategy (NDA, MAA preparation; Health Authority liaison)
  • Medical Affairs
  • Advertising and Promotion Review
    • Review of Independent scientific exchange materials, grant requests, and independent research study proposals
  • Commercial Compliance
    • Monitoring
    • Policy development
    • Compliance Support
  • Software Solutions
    • MyIndago A&P (Advertising and Promotion) and Health Authority Decisions (HAD)
    • NEW! DOC™Label* licenses and subscriptions, an exclusive partnership with Doctor Evidence


Click here to contact OneSource Regulatory and learn more about our affordable and flexible services and software solutions. Or call us at +1 (833) OSR-TEAM.

Click here to watch the MyIndago Introduction Video.

*OneSource Regulatory has partnered with Doctor Evidence, and now offers the DOC™ Label solution to pharmaceutical and biotech companies outside the Top 30 companies. DOC™Label is a centralized repository for structured and unstructured data contained in package inserts, including US and UK labels, allowing users to directly compare indications across labels. OneSource Regulatory offers licenses and subscription services through our exclusive partnership with Doctor Evidence.



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OSR knows MLR

Looking for the best Medical, Regulatory and Legal Reviewers to help support your MLR/PRC team?

OSR provides the following:

  • Expert Reviewers - 10-15+ Years Experience
  • Backed by an Experienced Leadership Team
  • Flexible Review Coverage - No Minimum Hours
  • NEW in 2019:
    • Recruit + Place + Support
    • Reviewer Mentoring Program
    • Review on Demand

Contact OSR to discuss your needs at OneSourceRegulatory.com

51626 Health Authority Decisions
52918 Supplement Documents
3450 A&P Enforcement - FDA/CIA/OIG

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Information To Help With Better Decisions

MyIndago provides the following benefits:

  • A single place to search and find answers to important questions
  • Unmatched search capabilities for letters, promotional materials and health authority information
  • Ability to annotate and save documents of interest in the MyLibrary feature for future reference
  • Opportunity to seek insights from colleagues and OSR
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MyIndago - SOLUTIONS

FREE - Unlimited Searches

A&P Enforcement - FDA/CIA/OIG and Guidance Documents, including:

  • FDA Office of Prescription Drug Promotion (OPDP)
  • FDA Advertising and Promotional labeling Branch (APLB)
  • FDA Center for device and radiological health (CDRH)
  • Dietary and Nutrional Supplements
  • Center for veterinary machines (CVM), Animal Health
  • Cosmetics
  • US Corporate integrity agreements and OIG advisory Options
  • FDA Advertising and Promotion Regulations/Guidelines Documents
  • New enforcement communications will be added upon issuance

FREE - MyLibrary Access

Annotate and Save Documents

FREE - Document Sharing

Send Documents of Interest to Colleagues

Open a Discussion around a Document

Create a free A&P Account
Check out the video now

Pricing plans

Check out our awesome plans tailored to meet your requirements.

Tier 1: Companies Ranked 1-50
Contact for Pricing

HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).

COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)

Tier 2: Companies Ranked 51-100
Contact for Pricing

HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).

COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)

Tier 3: Companies Ranked 101+ and Revenue generating
Contact for Pricing

HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).

COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)

Tier 4: Pre-Revenue
Contact for Pricing

HEALTH AUTHORITY DECISIONS Documents (FDA | EMA).

COMING SOON - FDA CBER Products, FDA Advisory Committee Documents)

Interested in working together? Get In Touch

Frequently Asked Questions

Q. What is MyIndago?

A single place to search and find answers to important questions.  Unmatched search capabilities for letters, promotional materials, and health authority information.

Q. What is the A&P Enforcement Solution?

A FREE Solution that allows you to search all FDA Enforcement Documentation, Annotate, and Save to MyLibrary for future reference.

Q. What is the Health Authority Decision Solution?

This Solution offers a single interface to search FDA Approval Documentation for thousands of approved drugs, compare docs, annotate, and save results!

Q. How do I use the MyLibrary Functionality?

Click the video below to learn about the great features available for saving documents, searches, and organizing your saved information!

Q. What is the MyCommunity?

Click the video to learn more about the Community Forum where current relevant topics are posted, and can be discussed/commented on.

Q. How do I request OSR Consulting Services?

To contact OneSource Regulatory and learn more about our affordable and flexible services and software solutions – Click the link below!

Q. Submit MyIndago Feedback?

Need to report an issue with the site, ask for help, or just want to send feedback, watch the video to find out how!

Q. A&P Case Study

Click the video now to walk through a Case Study Example from the A&P Enforcement Solution!

Q. HA Decision Case Study

Click the video now to walk through a Case Study Example from the HA Decisions Solution!

Get In Touch

If you have any questions, get in touch here.

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Telephone

+1 (833) OSR-TEAM

Send email

info@myIndago.com