The challenges of growing without a Quality Department
No formal QMS in place
Without a structured Quality Management System, early-stage teams face gaps in documentation, traceability, and compliance readiness.
Risk of delays & inspection findings
Lack of experienced oversight increases the chance of compliance issues, costly rework, and slower progress through clinical stages.
Long lead times & high hiring costs
Recruiting, training, and retaining Quality professionals takes months — and drains limited budgets when speed matters most.
Limited budgets and headcount
Early-stage companies must balance every euro and resource, making full-time Quality staffing impractical before revenue arrives.
Meet Your Virtual Quality Department
Full-service Quality leadership, on demand
-
We establish the structure and rhythm of your Quality function — defining SOPs, documentation, and governance processes that keep your projects inspection-ready and your teams aligned.
-
Our experts oversee audit preparation and inspection readiness, helping you anticipate regulatory expectations and avoid findings that could delay your clinical or commercial milestones.
-
A ready-to-deploy cloud-based eQMS gives you instant access to compliant templates, automated workflows, and full traceability without the cost or complexity of custom builds.
-
Gain access to a global network of proven Quality SMEs across GxP, Clinical, CMC, and Commercial — providing flexible, on-demand expertise precisely when and where you need it.
What you gain by outsourcing your Quality Department
Inspection readiness from day one
Be audit-ready at every stage of development with proactive compliance oversight, documentation control, and expert Quality leadership from the start.
Rapid access to skilled SMEs
Instantly tap into a global network of experienced Quality professionals across GxP, Clinical, CMC, and Commercial disciplines.
Cost efficiency
Replace the fixed cost of in-house Quality staffing with flexible, scalable support aligned to your budget and growth.
Seamless integration with your team
Our Virtual Quality Department operates as an extension of your organisation — collaborating within your systems and workflows for full visibility and control.
Enhanced credibility with regulators and investors
Demonstrate strategic Quality management that builds confidence among regulators, partners, and investors.
Faster speed-to-clinic
Streamlined systems and expertise remove bottlenecks, helping your teams reach clinical milestones faster.
Ready to discuss your pipeline with our Leadership Team?
-
Dr. Fitzgerald brings over 25 years of experience in the pharmaceutical industry, with a strong background in Technical Operations across the product lifecycle. For the past 15+ years, he has served as Head of Quality for organizations holding Clinical (IMPD/IND) and Commercial (MA/NDA/BLA) product authorizations. He is an active contract Responsible Person (RP) ensuring robust regulatory compliance and operational oversight and has hosted multiple Regulatory inspections (HPRA PAI WDA/MIA/MIA IMP, MHLW/PMDA MA) over the past 10+ years with no major findings.
-
Padraig Long has over 17 years of experience in the pharmaceutical industry, specializing in Quality Operations across both small and large molecule programs. He is an experienced Qualified Person (QP) for companies holding Clinical (IMPD/IND) and Commercial (MA/NDA/BLA) authorizations, with responsibility for batch certification and ensuring full compliance with the terms of each company’s Manufacturing and Importation Authorisation (MIA).
Scale your Quality function without the overhead
Book a free Quality readiness consultation to see how we can help your next milestone.
