OneSource Regulatory (OSR) has helped many small, early-stage companies move their products forward by providing the necessary expertise they need. Our team is your company’s best, singular resource for when you need help moving from the development stage to commercialization. We love 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 analysis 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. When you leverage OSR’s proprietary technology, you can make powerful labeling decisions and achieve label language that is directly linked to proven endpoints.

CMC

A 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

We can help you create a customized, cost-effective plan that can adapt as you grow.

Advertising & Promotion Review

OSR team members provide proven launch review experience.

Commercial Analysis & Operations

Analyze market opportunities and assess how to differentiate your product. Then you can build commercial infrastructure for the most optimal and efficient launch.

Commercial Planning

OSR can help you develop strategic and tactical launch plans to optimize your brand value. That includes preparing a commercial roadmap with timelines and a budget.

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