Early Stage Companies
OSR has helped many small, early stage companies move their products forward with the necessary expertise they need. We offer one place for you to go to get the help you need to move from development to commercialization. In fact, we really enjoy helping early stage companies achieve their goals. If you are looking for a valued partner to work with, please let us share our experience.
The OneSource Solution will help you successfully navigate each phase of drug development and FDA approval:
- Regulatory Strategy Development – Conduct a gap analyses of preclinical and clinical studies versus guidance documents, then build action steps and timelines to ensure you successfully progress through each phase of drug development.
- Labeling – OSR can help leverage opportunities to make modifications in clinical trial design to achieve desired label language that is directly linked to proven endpoints. Leverage proprietary OSR technology to empower your labeling decisions.
- CMC – Drug manufacturing strategy is critical for successful launch and commercialization. OSR can prepare HA filings and complete Module 3 with experienced CMC writers.
- Compliance Plan Development – Customized, cost-effective and adaptable as you grow.
- Advertising & Promotion Review – Proven launch review experience.
- Commercial Analysis & Operations – Analyze market opportunities and assess how to differentiate your product. Build commercial infrastructure for the most optimal and efficient launch.
- Commercial Planning – Develop Strategic and tactical launch plans to optimize brand value. Prepare commercial roadmap with timelines and budget.
ONESOURCE REGULATORY HELPS EARLY STAGE COMPANIES THROUGHOUT THE DRUG DEVELOPMENT CYCLE