Expert QP  and RP support for batch certification, product release, and GxP implementation. Our QP consultants provide flexible resource for organisations requiring qualified person oversight — whether for ongoing batch release, QP cover during vacancies, or advisory support for complex release decisions.

• Batch certification and product release

• QP cover and interim QP services

• Import testing and third-country batch release

• QP advisory for complex release decisions

• QP training and development programmes

• RP and WDA support

Audit Findings Cost More Than Audit Preparation

Regulatory inspections are increasing in frequency and scrutiny. Whether you're preparing for an HPRA, MHRA, FDA, or EMA inspection or managing a supplier qualification programme the cost of being underprepared far exceeds the investment in proactive audit readiness.

yes GxP provides expert-led GxP audits that go beyond checklist compliance. We assess your systems, processes, and culture against current regulatory expectations, giving you a clear, prioritised picture of your compliance position and a practical roadmap to address gaps before they become findings.

Regulatory Intelligence

Stay ahead of the regulatory landscape with expert interpretation of emerging guidance.

Regulatory requirements are not static. New guidance documents, inspection trend reports, and enforcement actions continuously reshape what regulators expect to see during inspections. Organisations that track and interpret these changes proactively maintain a stronger compliance posture.

Our regulatory intelligence service monitors key agencies — HPRA, MHRA, EMA, FDA, WHO — and translates emerging guidance into practical, actionable recommendations for your quality management system. We help you understand what's changing, what it means for your operations, and what you need to do about it.

Technical Depth When You Need It Most

Regulated organisations frequently face technical challenges that require specialist expertise — a complex deviation investigation, a sterility failure, a gap assessment ahead of a new product launch, or the need for a Qualified Person to support batch release. Recruiting permanent specialists for every discipline is neither practical nor cost-effective.

yes GxP provides flexible, expert technical resource across the full GxP lifecycle. Our consultants bring deep hands-on experience from pharmaceutical manufacturing, QC laboratories, regulatory affairs, and quality systems — available when you need them, for as long as you need them.

Disciplines Covered

• Risk & Gap Assessment

• Qualified Person (QP) Services

• Batch Release & Certification

• Deviation & CAPA Management

• Sterility Assurance

• Microbiology & Environmental Monitoring

• Regulatory Submissions & Technical Writing

• Change Management 

Quality Culture Assessments

A robust quality culture is the foundation of sustainable compliance. Our Quality Culture Assessments evaluate the human and organisational dimensions of your quality management system — examining leadership behaviours, employee engagement, communication, accountability, and the extent to which quality is embedded in day-to-day decision-making across your site.

• Leadership and management commitment review

• Employee quality awareness and engagement surveys

• Right-first-time and error reporting culture analysis

• Cross-functional quality behaviour benchmarking

• Culture improvement roadmap and action planning

• ICH Q10 Pharmaceutical Quality System alignment

Sterility Assurance & Microbiology

Specialist microbiology and sterility assurance support for pharmaceutical manufacturers, contract laboratories, and healthcare product companies. Our microbiologists bring deep expertise in environmental monitoring, sterility testing, bioburden assessment, and contamination investigations.

• Environmental monitoring programme design and review

• Sterility assurance programme development

• Contamination investigation and root cause analysis

• Bioburden and endotoxin testing strategy

• Microbiology SOP and method development

• Annex 1 sterility assurance compliance support

Why Generic Training Falls Short

Most compliance training is built for the broadest possible audience — which means it rarely speaks directly to your team's roles, your site's processes, or your regulatory context. Staff disengage, knowledge doesn't transfer, and audit findings repeat.

At yes GxP, we take a different approach. Every training programme we build starts with a thorough needs analysis — understanding your organisation's gaps, your regulatory obligations, and the specific competencies your people need to perform their roles compliantly and confidently.

Our Approach

Every programme starts with understanding your organisation.

• Regulatory context & applicable GxP standards

• Role-specific competency requirements

• Existing training matrix & identified gaps

• Audit history & CAPA actions

• Preferred delivery format & learner profile

Off-the-Shelf GxP Programmes

Ready-to-deploy compliance training across all core GxP disciplines.

Not every organisation needs a fully bespoke programme. Our library of off-the-shelf GxP courses covers the essential compliance topics required across pharmaceutical and life sciences sectors — available online or in-person.