Advancing therapeutic treatments with efficiency and accuracy
We offer a range of early phase contract services executed by professionals fully dedicated to your early development program. These services include:
· Consulting and Design
· FIH, POC and Clinical Pharmacology – Protocol Design and Writing
· Consulting for registration strategy and drug development in China, the US and other regions worldwide, from IND to NDA
· Pre-IND consultation in cell therapy
· Writing and Submission for Application Dossiers
· HGRAC Application
Accelerated timeline to Early Phase Clinical Trials
| · | Strict compliance with NMPA regulations and ICH guidelines |
| · | Extensive project experience in identifying and preventing potential risks |
| · | Designing First-in-Human(FIH) studies based on nonclinical data while guiding nonclinical research with the end goal of clinical development in mind |
> Design and select biomarkers
> Clinical POC of biological pathways
> Biological targets
> Surrogate endpoints
> Risk Management
> Accelerate clinical development
Globally customized development solutions for drug commercialization
· Develop global registration strategies
· Analyze different regulatory requirements and map out the best development path
· Communicate effectively with regulatory authorities to ensure smooth registration and submission processes
We pride ourselves on our abilities to guide global drug developers of all sizes today, tomorrow, and into the future.
