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Eliminating Critical cGMP Risks Before They Become Inspection Failures.

Regulatory observations, repeat findings and systemic deviations are not isolated events. They signal structural weakness inside quality systems.

We step into complex manufacturing operations to identify, prioritise and remediate the cGMP failures that trigger inspections, warning letters and operational shutdown risk.

Our work stabilises sites under regulatory pressure and builds the governance required for sustained compliance and responsible growth.

We support pharmaceutical manufacturers, CDMOs, cosmetic and private equity investors who require regulatory control, operational stability and protected enterprise value.

Request a confidential discussion with our management team.

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Global Aseptic CDMO

Senior Global Director QA

CCS in 6 weeks project

“The whole project was very professionally handled. The experience and knowledge of the Pharmalliance team was outstanding and helped much overcoming misunderstandings and knowledge gaps on our side. Deliverables were provided in time and Pharmalliance kept us on track.”

Sterile Ophthalmic CDMO

QA Remediation Lead

cGMP Remediation Project

“Pharmalliance delivered exactly what we needed – fast, relevant, and high-quality training tailored to our remediation project. 

The content was precise and aligned with FDA and EMA expectations for Sterile Manufacturing. Their willingness to adapt the program made a real difference for our team.” 

Irish OSD CDMO

Executive Project Lead

Drug Shortage Remediation

“Pharmalliance supplied a team of QA and Engineering specialists who assisted in an operation and quality excellence improvement project. 

The result was a marked increase in throughput, which help eliminate a shortage of supply to the market, and a major drop in production downtime.”

Some of our happy clients

Pfizer logo
Scope Logo
valneva logo

Key Services to Increase cGMP Compliance

Person performing facility audit

Risk Due Diligience

Identify GMP and Annex 1 risks early so issues never escalate into findings or delays. Strengthen confidence in your facility with clear, structured assessments that support compliance and investment.

Quality system setup

Operational Readiness

Prepare teams and processes for reliable, compliant commercial operation from day one. Build strong QMS foundations and audit-ready controls that enable long-term performance.

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Strategic Oversight

Ensure facilities and processes qualify smoothly and stand up to regulatory scrutiny. Strategic oversight from early design to PQ reduces rework and accelerates commercial readiness.

GMP Documentation

Regulatory Readiness

Enter FDA or EMA regulatory inspections and PAIs with clarity, control and complete documentation readiness. Mock audits and structured preparation help you deliver consistent and confident outcomes.

Engineering and validation services

Contamination Control

Reduce contamination risk with a pragmatic, risk-based approach aligned to EU Annex 1. Our CCS programs and CPD training strengthen prevention and improve audit outcomes across all product types and modalities.

Compliance As A Service

GMP Remediation

Recover quickly from compliance issues with targeted remediation and expert onsite support. Stabilise your QMS, close gaps and return operations to sustainable GMP performance.

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Address

Glasshouses G2,92 George's Street LowerDún Laoghaire, Dublin, A96 VR66, Ireland

Phone

+353 (0)1 969 2000

Email

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