Drug Product Labeling
End-to-end labeling capabilities
Starting from development of the Target Product Profile (TPP), to the creation of the Company Core Data Sheet (CCDS), through to the development of physician and patient labeling content for the US, EU, and across the globe; we provide unmatched expertise. We are experts in:
- FDA and general Health Authority labeling negotiations
- Authoring, editing and preparation of routine new product submissions, labeling supplements, amendments and labeling section of annual reports
Complex labeling projects
In addition, we have significant expertise in complex labeling projects, such as:
- Drug product labeling alignment – aligning your local labeling to your CCDS does not require expensive consultants who do not have the relevant background to manage and complete an alignment initiative. OneSource Regulatory can help develop a customized plan and recommend technology solutions for labeling alignment.
- Labeling migration – does your drug product labeling reside on disparate systems across your affiliates, or worse, on the desktops or email systems of your employees? OneSource Regulatory can help your organization migrate your labeling into one system. Our team and our expert operations partners have successfully completed migrations at large pharmaceutical companies.