Bioanalytical Method Development and Method Transfer
Method Development and Transfer with CMIC USA
Method Development Expertise
Bioanalytical method development is a critical phase in drug development, requiring meticulous attention to detail. Whether you require method transfer or the development of a new assay from scratch, our team excels in guiding your project to its desired endpoint. We emphasize clear communication and understanding between Sponsor and CRO, recognizing the pivotal role it plays in achieving successful outcomes.
Our process begins with a thorough feasibility assessment, where we evaluate different method options to determine the most suitable instrument platform. This strategic approach not only optimizes technical efficacy but also ensures financial efficiency by selecting the method that best fits your budget without compromising on quality.
Comprehensive Services
From initial feasibility assessments to final validation or fit-for-purpose qualification, we offer comprehensive services to meet regulatory requirements effectively. Our experienced team is adept at navigating the complexities of bioanalytical development, ensuring compliance with stringent regulatory standards.
Why Choose CMIC?
- Dedicated Project Commitment: Each project is overseen by a single principal investigator, ensuring continuity and in-depth knowledge of your development program from method transfer through validation.
- Direct Communication: Enjoy direct access to your PI, fostering a strong scientific partnership and facilitating swift resolution of any project-related queries.
- Advanced Technology: Benefit from our extensive array of chromatography and ligand binding platforms, allowing us to conduct thorough feasibility testing and select the optimal method that guarantees high quality and reproducibility within your budget.
- Specialized Experience: With a proven track record in oligonucleotide method development and validation, we bring unparalleled expertise to quickly troubleshoot any challenges that may arise.
