Services

Consultants

   


Examples of current consulting work:

1. Antibody drug conjugate IND filing package preparation;

2. Biosimilar product development FDA advisory meeting preparation;

3. Breakthrough product BLA filing;

4. Fast track designation request package preparation;

5. Orphan drug desingation request

6. Audition of the finished drug product and drug substance manufacturing facilities;

7. 505 b(2) application for small molecule

8. Qualified infectious disease product development

  

A Word About the Journey

   

Drug development especially biologic product development is our specialty, interest and highly experienced subjects. Our consultants carry more than 17 years of regulatory and industrial experience to help our clients to pave their smooth US drug development pathway.

  
   

We are specialized in biologic product consulting from CMC, preclinical GLP study design, protocol review to clinical study deisgn, data analysis, study report preparation, PK/PD modeling & simulation. No matter what kind of biologic products you have: classic IgG, antibody drug conjugate, nanobody, Fc fusion protein, bispecific antibodies, PEGylated protein, antibody-enzyme fusion, enzyme products, cytokines, and radiolabelled antibodies. No matter it is a novel protein or a biosimilar, it is expressed from mammalian cells or bacteria, as long as you can create it, we can lead you to the right regulatory pathway.