Labeling Development and Support
"The OSR team helped us write our best label to submit to the FDA."
Our support model is simple – we are flexible and only provide the services you need when you need them. No job is too small or too large.
The OneSource Regulatory™ team includes experienced staff to help companies develop HCP and consumer labeling for prescription drugs and biologics. We lead, assist, and collaborate with your team to develop the best product labeling strategy and content. We offer the latest technology solution – OSR DOC Label™ – to help you reach your goals.
What We Do
OneSource Regulatory™ provides strategic support to your team. Our experienced staff can manage the entire product labeling process, including development of:
- Company Core Data Sheets (CCDS)
- U.S. package inserts
- Medication guides
- E.U. Summary of Product Characteristics (SPC)
- Patient Information Leaflets (PIL)
Develop labeling content, manage and support complex labeling and regulatory situations, manage health authority communications, and assist in the design of your company’s labeling policy and process - that's what we do at OSR.
The Tools You Need with a Click of a Button!
OneSource Regulatory™ has partnered with Doctor Evidence to become the exclusive reseller of DOC Label™.
DOC Label™ is a database of all labels from the FDA, the U.K., and global territories that allows companies to retrieve and compare labeling content. Research that takes weeks to complete manually can now be completed in minutes. You also have the assurance that you have covered all available labels, not just those your team remembers from experience.
Use DOC Label to Drive Your Strategy
- Use competitive labeling intelligence to differentiate your product in the marketplace.
- Document labeling precedence to support your discussions with health authorities.
- Respond quickly to FDA comments with compelling evidence to support your position.
- Empower your pharmacovigilance surveillance.