Why OSR?

OneSource Regulatory (OSR) Drug Product Labeling Strategy includes experienced team members with over 15 years of experience helping companies with prescription drugs and biologics. We lead, assist or collaborate with your team to develop the best label possible. And, don’t forget: we also deploy the latest technology, the DOC Label™ Solution, to help you reach your goals.

What We Do

OneSource Regulatory helps by providing strategic labeling support to your team, or we manage the entire labeling process for you with our experienced staff. Including:

  • Company Core Data Sheets (CCDS)
  • US Package Insert
  • Medication Guide
  • EU Summary of Product Characteristics (SPC)
  • Patient Information Leaflets (PIL)
  • Manage and support complex labeling and regulatory situations
  • Health authority communications support
  • Labeling policy and process design

Support Models

The key is to get the support you need when you need it. The OSR flexible support model gives you the expertise at the times it makes sense, such as launch or peak periods as well as support for legacy products. Just let us know what you need:

  • Up to 10 hours a week
  • 10 – 20 hours a week
  • 20 – 30, or
  • 40 hour per week or more


TAKE THE NEXT STEP

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Leveraging Technology

Technology Tools for Labeling at the Simple Click of a Button!

OneSource Regulatory has partnered with Doctor Evidence and is the exclusive value-added reseller of the DOC Label™ Solution for pharmaceutical and biotechnology companies. The DOC Label™ Solution, a complement to OSR labeling services, enables small and medium pharma and biotech companies to leverage this powerful solution, until now only available to large companies.

The DOC Label™ Solution retrieves and compares results from a database of all FDA and UK drug labels as well as any global territory’s local uploaded label with the click of a button. Research that takes weeks to complete manually can now be completed in minutes, along with the assurance that you’ve covered the entirety of available labels (and not just those your team remembers from experience.)

Leverage this powerful technology to drive strategy:

  • Gather competitive intelligence when drafting your label so you can clearly differentiate your product in the marketplace
  • Document prior precedence language from the entire landscape of available labels to support your discussions with health authorities
  • Respond quickly to FDA responses to submissions with compelling evidence to support your case
  • Empower your pharmacovigilance efforts – by automating the tracking of competitors’ labels around key attributes
  • Easily compare your company’s label versions to ensure global labeling consistency and quality

SIGN UP FOR A FREE DEMO

  • Contact OSR today and start to realize the strategic and time/resource-saving benefits of technology-enabled labeling today!
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