POST MARKET SOLUTIONS
Work with us to benefit from our expertise, extensive network, and commitment to supporting your post-market needs - from validation and regulatory navigation to commercialization and local market access.
Post-Market Services
At Unilabs Pharma Solutions, we provide comprehensive post-market support for precision diagnostics and companion diagnostics (CDx), helping you bring innovative solutions to patients efficiently and effectively.
Companion Diagnostics and Precision Diagnostics for Targeted Therapies
The Dx/Rx partnership is a well-established paradigm when developing new precision diagnostic tests. At Unilabs Pharma Solutions, we propose the addition of the Lx—the laboratory CRO—to support the entire process, from development to market access and commercialization.
We offer a flexible model for supporting precision diagnostics that can be modulated to fit the needs of different markets. Our services are designed to accelerate the commercialization of new diagnostic tests and companion diagnostics, whether through central or localized laboratory support.
What we offer
We offer a range of key services designed to facilitate the commercialization and application of precision diagnostics:
- A rich toolbox of CDx-relevant technology
- An exceptional menu of services supporting clinical trials, diagnostic development, and commercialization
- Intimate knowledge of local testing standards and regulatory requirements
- Speed and efficiency in method development and transfer
- Competence in navigating logistical challenges throughout Europe and North America
Applications:
Our companion diagnostics play a critical role in various applications:
- Enhances Integration of Diagnostics with Therapeutics: We bridge the gap between diagnostics and treatment, ensuring optimal patient outcomes.
- Facilitates Market Access for New Precision Diagnostic Tests: Our services support the introduction of innovative diagnostic tests across Europe and North America.
- Companion Diagnostic Development and Validation: We assist in the development and validation processes to ensure efficacy and safety.
- Drug-Diagnostic Co-Development Support: Our collaborative approach fosters successful partnerships in developing integrated solutions.
Instrumentation:
We utilize advanced instrumentation to deliver high-quality results:
- Advanced Bioanalytical Platforms: Our state-of-the-art technology ensures precise analysis and data integrity.
- High-Throughput Analytical Systems: We provide scalable solutions to meet the demands of high-throughput testing.
- Validated IVD Testing Equipment: Our equipment meets stringent regulatory requirements, ensuring dependable results.
Advanced bioanalytical platforms enabling high-throughput, reliable companion diagnostic development and precision medicine integration.
Comprehensive Process Support:
Unilabs supports the entire process of precision diagnostics, from order placement to patient treatment:
- Physicians place orders via a tailor-made website.
- Logistics send out sample kits.
- Physicians take samples from patients.
- Samples are picked up by courier.
- Analytical tests are conducted in our labs.
- Test results are delivered for patient treatment.
Integrated Project Support:
Each project incorporates essential components for success:
- Project Management
- Logistics
- Sample Collection Kits
- Data Management
- Assay Development & Validation
With our trusted bioanalytical expertise and advanced capabilities, we are dedicated to supporting the future of companion diagnostics and precision medicine. Contact us to learn more about how we can collaborate in advancing your diagnostic solutions.