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, 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 to identify and prevent potential risks |
| · | Early design for clinical trials with nonclinical data, while guiding the conduct of nonclinical research with the objective of clinical trial design |
> Design and select biomarker
> Clinical POC of biological pathway
> Biological target
> 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 with regulatory authorities thoroughly to ensure smooth registration and application
We pride ourselves on our abilities to guide global drug developers of all sizes today, tomorrow, and for the future.
