Too often early R&D programs do not take into consideration the future regulatory and clinical requirements for getting a Biomarker to market. Based on the regulatory path that we will define for you, we can help you optimize each step of your research and development plan from concept to marketing strategy. In this way, you will have a more accurate estimate of your technical and financial needs.
Trans-Hit Biomarkers can assist you with designing and planning the regulatory strategy for all international markets. Our team has extensive experience with:
- U.S. FDA filings of In Vitro Diagnostics (Pre-IDE Meeting, IDE, IVD, IVDMIA)
- Regulatory filings in Europe: technical documents for CE Mark, liaison with notified bodies, and developing and submitting CE Mark filings for EU
- Regulatory filings in Canada, Japan and Australia
No matter the size of your institution or company, private or public, we tailor our services to your needs, providing you with customized services. Our corporate goal is to develop long-term relationships and commitments with our clients and to provide high-quality, comprehensive services and expert support.
Trans-Hit Biomarkers offers a selection of services to pick and choose from to fit your individual development needs.
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- Regulatory planning and design
- Full regulatory support, preparing dossiers and acting as a liaison with regulatory authorities
- Hourly regulatory consulting for “simple” questions or presentations
- Quality System Management planning
- Standard Operating Procedure (SOP) development
- Organizational gap analysis
- Marketing strategy and planning, based on regulatory path
- Labeling, packaging and advertising development within the regulatory framework