Expert Regulatory Assistance for Biologics: 20 Years of Excellence
We offer unparalleled expertise and dedication to support your clinical programmes through every stage of the regulatory pathway.
Comprehensive support for IND and IMPD dossier filing
We are aware that regulatory dossier submission is time-consuming and can be challenging, especially for biopharmaceutical companies with limited resources. As a client-focused CDMO, we are committed to helping our customers navigate through the intricacies of regulatory processes.
For INDs/IMPDs applications, our comprehensive collaboration extends to the seamless integration of all quality documents into the CMC sections of the filing. In addition, our meticulous in-line review helps improve accuracy and avoid unnecessary authority requests or time-consuming corrections.