Quality Systems
Validation
Equipment qualification (IQ/OQ/PQ), method qualification/validation, computer system validation (CSV), cleaning validation where applicable.
QMS
SOPs, training, document control, change control, deviation/CAPA, supplier qualification.
QMS
SOPs, training, document control, change control, deviation/CAPA, supplier qualification.
Data Integrity
Data Integrity: ALCOA+ by design; audit-trail reviews; backup/restore testing.
Data Integrity
Data Integrity: ALCOA+ by design; audit-trail reviews; backup/restore testing.
Environmental Monitoring
Environmental Monitoring (EM): Viable/non-viable particulates, settle/contact plates, routine trending with action/alert limits.
Environmental Monitoring
Environmental Monitoring (EM): Viable/non-viable particulates, settle/contact plates, routine trending with action/alert limits.
Global Quality & Compliance
Operations designed to meet and exceed FDA and EMA regulatory standards.
Global Quality & Compliance
Operations designed to meet and exceed FDA and EMA regulatory standards.
Let’s Build the Future of Advanced Therapies, Together.
Let’s Build the Future of Advanced Therapies, Together.
Let’s Build the Future of Advanced Therapies, Together.
Let’s Build the Future of Advanced Therapies, Together.
Copyright © 2025 Nucelion All rights reserved.
Copyright © 2025 Nucelion All rights reserved.
Copyright © 2025 Nucelion All rights reserved.