Early Development & Regulatory Affairs

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.

How can we help? Please fill in the form below, and we will contact you as soon as possible.