Regulatory: Designed to meet the Expectations of Regulatory Agencies Worldwide
Chorus's regulatory affairs group supports the needs of each asset from nonclinical testing through first-in-man studies and proof of concept.
Chorus's regulatory affairs group supports the needs of each asset from nonclinical testing through first-in-man studies and proof of concept.
Our activities are designed, with emphasis on ICH good clinical practice (GCP), to meet the expectations of regulatory agencies worldwide as established by the:
We are specifically governed by directives, guidelines, and regulations of bodies such as the WHO, ICH, CFR, and EU, and by applicable specific country and state regulations.
Implementation of work (i.e., clinical trial authorizations, investigational new drug applications, clinical trial notifications, maintenance of open applications, and clinical trial safety/pharmacovigilance) occurs in collaboration with experienced partners.
- World Health Organization (WHO);
- European Union (EU);
- US Code of Federal Regulations (CFR); and
- International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
We are specifically governed by directives, guidelines, and regulations of bodies such as the WHO, ICH, CFR, and EU, and by applicable specific country and state regulations. Implementation of work (i.e., clinical trial authorizations, investigational new drug applications, clinical trial notifications, maintenance of open applications, and clinical trial safety/pharmacovigilance) occurs in collaboration with experienced partners.