> >
Quality control/Audits

Quality control/Audits

Vita Aeterna company works per quality standard ISO 9001:2015. Vita Aeterna company works per own system of Standard operating procedures (SOP). On the request of a Customer and during corresponding trainings, the company can follow the customer’s SOPs. The quality Assurance Department of Vita Aeterna guarantees continued functioning of the quality control system in clinical studies in accordance with the national regulatory requirements, corporate standards of “Vita Aeterna” LLC, general ICH-GCP requirements, registration dossiers and other documents regulating pharmaceutical activity.

Services:

Arrangement and conduct of independent audits of CT/study sites;

Independent audits of clinical/preclinical study partners (laboratories, study sites, preclinical study bases);

Arrangement and conduct of professional seminars/trainings including:

(1)    Fundamentals of ICH-GCP. Arrangement and conduct of CT

(2)    CT monitoring

(3)    CT project management

(4)    Guidelines on handling of a study product, etc.

Preparation to inspections and their support;


Order

CAPTCHA