cGMP Due Diligence?
Quantify cGMP Risks Before Capital Is Deployed.
We identify systemic cGMP exposure, inspection vulnerability and remediation cost drivers before transaction close across sterile, non-sterile, ATMP facilities.
3 Outstanding Benefits of our Due Diligence 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 Due Diligence Program can help if this is you:
The Problem
Manufacturing assets frequently carry latent cGMP, facility and utility exposure that is not visible in financial diligence.
​
When these risks surface during inspection, deviation trends or contamination events, they can lead to regulatory action, product recalls, delayed expansion and significant value erosion.
The Goals
Provide expert independent visibility into regulatory and manufacturing risk before transaction close.
​
Quantify compliance gaps, inspection exposure and infrastructure liabilities to inform investment decisions, remediation strategy and capital deployment planning.
The Company
Mid-market and upper mid-market Private Equity firms investing in European pharmaceutical manufacturing platforms.
​​
Investors acquiring sterile, biologics, ATMP and oral solid dose operations across Western and Central Europe seeking independent regulatory risk visibility.
6 Reasons to Join the Facility Compliance Program
Regulatory Risk Clarity
We provide independent cGMP and sterile manufacturing risk assessment that exposes compliance and operational risks not visible in financial diligence.
Value Erosion Prevention
We identify latent compliance weaknesses that can trigger inspection findings, recalls, import alerts, remediation CapEx and post-close instability.
Pharma Trust Index (PTI) Insight
Through our Pharma Trust Index (PTI), investors gain structured regulatory scoring across historical regulatory compliance actions converted into a C-AAA scoring model.
Realistic Remediation Forecasting
We translate real regulatory exposure into clear remediation scope, cost drivers and operational impact assumptions to support informed capital allocation.
Full-System Exposure Mapping
We assess facilities, utilities, manufacturing processes, QMS performance, organisational structure, training adequacy, and KPI reliability to uncover systemic risk.
Post-Close Stabilisation
We mobilise experts to lead structured remediation and governance programmes to restore regulatory control and embed sustained compliance across the platform.
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. ”
