Pharmaceutical Due Diligence, Resilience & Remediation.
Independent Regulatory & GMP Risk Partner to Investors and Pharmaceutical Manufacturing Platforms.
We assess, quantify and mitigate regulatory and manufacturing risk before and after capital deployment, enabling pharmaceutical platforms to scale with confidence.
Request a Confidential Risk Discussion
Speak directly with a senior partner about regulatory, sterile or platform risk exposure.
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
Regulatory & Sterile Manufacturing Risk Expertise Across the Full Investment Lifecycle
Manufacturing platforms lose value when regulatory and sterile risk is identified too late — during inspection, integration, or expansion. We take a different approach.
We quantify regulatory and sterile manufacturing risk before capital is deployed, and we lead remediation, platform integration and infrastructure oversight post-acquisition.
From due diligence through operational stabilisation and capacity expansion, we embed Annex 1 discipline, contamination control and risk-based governance into every stage of the manufacturing lifecycle.
We support private equity investors, CDMO platforms and pharmaceutical manufacturing sites across sterile, biologics, ATMP and oral solid operations in Europe and globally.
Explore our engagement models below.
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Address
Glasshouses G2,92 George's Street LowerDún Laoghaire, Dublin, A96 VR66, Ireland
Phone
+353 (0)1 969 2000
