Bridging Nanotech Innovations to Healthcare Solutions
We are dedicated to advancing the field of translational medicine by providing expert guidance in the development and translation of innovative nanotechnologies. Our goal is to facilitate the smooth transition of scientific discoveries into effective, real-world medical solutions that improve patient outcomes and enhance the quality of care in the healthcare industry.
Our Consulting Services
including but not limited to
Preclinical Data Package Development
Guidance on necessary data for IND submissions. Strategies for effective data presentation to regulatory bodies.
Scale-Up of Nanoparticles
Solutions for manufacturing scale-up challenges. Quality control and assurance during scale-up processes.
CMC (Chemistry, Manufacturing, and Controls) Development
Assistance in process optimization for nanotechnology products. Consultation on drug substance (DS), drug product (DP) and phase-appropriate CMC development strategy.
Bioanalytical Assay Method Development
Supporting the design and oversight of GLP-compliant toxicology studies
GLP Toxicology Program Development
Development and validation of bioanalytical methods. Integration of bioanalytical data into the overall development strategy.
Container-Enclosure System Design
Selection and design of appropriate container systems for nanomedicines. Compatibility and stability testing of container systems.
Infusion Set Compatibility Development
Assessment and validation of infusion systems. Compatibility studies for nanotechnology-based therapeutics.
Clinical Trial Material (CTM) Development for Phase 1 Trials
Guidance on formulation and preparation of CTMs. Supporting the regulatory strategy for early-phase clinical trials.
Nanotechnology Platform Assessment
Constructive evaluation of clients' nanotechnology platforms for clinical translation potential. Identification of potential hurdles and major challenges/risks during the IND submission, with strategies to overcome them.
Nuclear Imaging and Biodistribution Strategy
Consultation on nuclear imaging techniques and radiolabeling for nano-platforms. Guidance in the selection of radioisotopes, chelator conjugation and in vivo biodistribution evaluation
About Us
Chen Translational Research Consulting LLC is dedicated to advancing translational medicine through the development and translation of innovative nanotechnologies. Our mission is to bridge the gap between preclinical research and clinical application, leading to improved patient outcomes and enhanced quality of care in the healthcare industry.
Contact Us
For inquiries and consultations, please reach out to us.