Facet Life Sciences: Getting you to and through the FDA
Facet Life Sciences can help you to formulate an effective development plan and strategies to execute on that plan. Your goals are our goals and are as important as the product(s) you are trying to develop. This mindset drives our partnerships with clients.
Facet’s Product Development Champions provide the following core product development services:
- US Agent (FDA Agent) activities
- Clinical, CMC, nonclinical, and/or regulatory gap analysis
- “You are Here” program evaluation
- Regulatory submission leadership, planning, and project management
- Preparation and support for health authority meetings
- Nonclinical, CMC, and clinical scientific strategic guidance
- Scientific medical writing of submission documents
- Regulatory and scientific review of submission documents
- Orphan drug and rare disease development activities
- Small business development activities (e.g., small business waivers)
A document management solution should streamline authoring processes while protecting valuable content. If it doesn’t, it isn’t the right tool. Facet Life Sciences is redefining document management for small teams with Gemstone eDMS. Our simple, secure and compliant tool was designed with a steadfast commitment to supporting small, innovative teams with right-sized technology solutions.
Brands: Gemstone Document Management Solution