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.
A global regulatory expertise
Drawing upon our robust 20-year history in manufacturing innovative biologics, our team has garnered a strong reputation for successfully submitting applications to multiple regulatory agencies (EMA, FDA, and NMPA). Comprising seasoned professionals in biologics regulatory affairs, our team brings diverse expertise in operations, quality assurance, quality control, and process development.
Leveraging the collective experience of our multidisciplinary team, we are confident that our processes and documentation adhere to the stringent criteria set by leading regulatory agencies.
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.
Partner with us today and ensure seamless regulatory compliance for your biologics!
Partner with GTP Bioways CDMO for seamless transitions and unlock success in your biotherapeutics development journey!
