Eliminating Critical cGMP Risks Before They Become Inspection Failures.

Name: Pharmalliance Consulting Ltd.
Address: 92 George's Street Lower, Dublin, D, A96 VR66, IE
Telephone: +353 (0)1 969 2000

Regulatory observations, repeat findings and contamination events are not isolated events.

They signal structural weaknesses inside quality systems weaknesses that surface during inspections and regulatory scrutiny.

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

Our mandates stabilise sites under regulatory pressure and restore the control required for sustained compliance and responsible growth.

We work with pharmaceutical manufacturers, CDMOs, cosmetic companies and private equity investors who require regulatory certainty, operational stability and protected enterprise value.

Request a confidential discussion with our management team.

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

Key Services to Increase cGMP Compliance

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.

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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.

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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.

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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.

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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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