Facility Compliance Risk Governance.
Identify and Remediate cGMP Gaps Fast.
Sterile, non-sterile, ATMP and cosmetic facility risk identification and remediation that stand up to inspection.
3 Outstanding Benefits of our Facility Compliance Fast-Track Program
Fast visibility of your highest-risk GMP gaps across facility, utilities + equipment.
A regulator-ready remediation roadmap (QRP) you can execute and defend.
Expert support through the program from Pharmalliance experts.
Who This is Program For?
Our Facility Compliance Program can help if this is you:
The Problem
Manufacturers carry hidden cGMP facility and utility risks that only surface during inspection, deviations, or contamination events. These risks can result in regulatory observations.
The Goals
To take a Quality Risk Management (QRM) approach to rapidly identify, prioritize, and remediate facility-related cGMP risks with an inspection-defensible plan.
The Company
Sterile manufacturers, CDMOs, ATMP facilities, and cosmetic manufacturers operating ageing or complex GMP facilities in Europe and USA.
6 Reasons to Join the Facility Compliance Program
Risk-Based Prioritization
The program uses ICH Q9-aligned risk assessment tools to help you identify, score, and prioritize risks, ensuring efforts are focused where they have the greatest impact on facility compliance.
Cross-Functional Alignment
​Align Engineering, Quality, and Operations through a unified risk framework that eliminates siloed remediation efforts and strengthens inspection defensibility.
Rapid Gap Visibility
​Gain structured visibility of your facility, utility, process cGMP compliance gaps so leadership can act decisively before inspection findings or product impact occur.
Accelerated Compliance Execution
​Implement practical, structured remediation tools and templates that reduce wasted effort and accelerate measurable progress toward sustained GMP compliance.
Quality Remediation Plan (QRP)
Develop a regulator-ready Quality Remediation Plan (QRP) that clearly links identified facility, utility and process risks to corrective actions, timelines, and accountable ownership.
Long-Term Governance Control
​Embed a sustainable facility compliance governance model that reduces repeat deviations, improves oversight, and strengthens inspection readiness over time.
Some of our happy clients
Testimonials
Senior Director, Global CDMO
"The experience and knowledge of the Pharmalliance team was outstanding and helped much overcoming misunderstandings and knowledge gaps on our side."
QP + Quality Head, Vaccines
"Pharmalliance helped with a CCS development project where there was a great deal of pressure to go very quickly. They were very effective strategizing what needs to be done."
QA Manager, Sterile OTC
“We faced numerous technical challenges, but their service delivered brilliant solutions. Their hands-on approach meant we felt supported throughout the project. ”
