Governance and Leadership
Strong quality governance provides accountability, regulatory confidence, and clear decision‑making across the organisation. Effective leadership roles ensure that quality is embedded at the right level and maintained throughout the product or laboratory lifecycle.
QP/RP Services
We provide experienced Qualified Person (QP) and Responsible Person (RP) support in line with EU regulatory requirements. Our experts ensure batch release, regulatory oversight, and ongoing compliance with applicable GxP obligations.
QA Resources and Consultancy
We offer flexible QA consultancy—from targeted advisory support to embedded QA roles. This allows organisations to scale quality expertise as needed while maintaining continuity, independence, and regulatory alignment.
Quality System
A robust quality system is the backbone of compliance, consistency, and inspection readiness. Well‑designed systems enable organisations to manage risk, demonstrate control, and scale operations sustainably.
Quality Management System (GxP and ISO)
We support the design, implementation, and optimisation of quality management systems (QMS) aligned with GxP and ISO standards. This includes gap assessments, system harmonisation, and pragmatic solutions tailored to the organisation’s size and maturity.
Quality Agreements
Clear quality agreements and effective supplier oversight reduce ambiguity and compliance risk. We support drafting, reviewing, and managing quality agreements, as well as supplier qualification and ongoing performance monitoring.
Risk Management and Quality Planning
Risk‑based thinking is central to modern regulatory expectations. We support structured risk assessments to identify critical processes, prioritise controls, and support informed decision‑making across operations.
Operational Quality and Compliance
Operational quality ensures that day‑to‑day activities are performed consistently, safely, and in compliance with regulatory requirements. These processes maintain control throughout the product, system, or laboratory lifecycle.
Qualification and Validation
We support qualification and validation activities to demonstrate that facilities, equipment, systems, and processes are fit for intended use. Our approach is risk‑based, compliant, and aligned with current regulatory expectations.
Change Control and Lifecycle Management
Structured change control ensures that modifications are assessed, approved, and implemented without unintended impact. We help establish lifecycle management processes that maintain compliance from initial implementation through retirement.
Deviations and CAPA management
Effective deviation and CAPA management is essential for continuous improvement and inspection readiness. We support investigation, root cause analysis, and the development of corrective and preventive actions, including effectiveness checks that address both symptoms and systemic issues.
Laboratory Environment and Compliance
A compliant laboratory environment protects people, data, and results. We support laboratory working environment compliance, including safety practices, roles and responsibilities, and alignment with applicable regulatory and occupational requirements.
Audits and Inspections
Independent oversight provides assurance that quality systems are effective and compliant. Audits and assessments are critical tools for identifying gaps before they become regulatory findings.
Audits and Internal Audits
We can provide our clients with audit support which scales from a single specialised audit to full management and execution of a company’s annual audit plan within GxP (GMP, GCP, GLP and ISO standards ) for all audit types investigator sites/facilities, vendors, process/system and documentation. Our audits are risk‑based, practical, and designed to provide clear, actionable outcomes.
ISO assessment and accreditation support
We support laboratories through ISO accreditation and certification processes, including ISO 9001, ISO 17025, and ISO 15189. This includes readiness assessments, documentation review, and support during conformity assessments.
Inspection Readiness and Inspection support
Inspection readiness is an ongoing state—not a one‑time activity. With our former inspectors we can support you with inspection readiness assessments, inspection preparation (of sites, service providers or sponsor), mock inspections, on-site inspection and post-inspection follow-up support.
Pre-clinical and Clinical Quality
Quality in preclinical and clinical development is essential to protect study participants, ensure data integrity, and support reliable regulatory decision‑making. A structured, risk‑based quality approach enables sponsors to maintain control while scaling development activities.
Pre-clinical and Clinical Project Management
We support preclinical and clinical projects with quality‑focused project management aligned with development and regulatory milestones. This includes planning, coordination, and integration of quality activities to ensure timelines, responsibilities, and deliverables are clearly defined and controlled.
GCP QA Management
Our GCP QA management services ensure that clinical activities comply with applicable regulations and ICH GCP requirements. We support the establishment and maintenance of GCP‑compliant systems, procedures, and oversight models tailored to the sponsor’s organisation and trial portfolio.
Sponsor Oversight
Effective sponsor oversight is a regulatory expectation and a key risk‑control mechanism. We support sponsors in defining and implementing proportionate oversight of CROs, vendors, and trial sites, ensuring accountability, transparency, and continuous quality assurance throughout the trial lifecycle.
Training and Development
Sustainable quality depends on knowledgeable people and consistent understanding of regulatory expectations. Training and competence development are essential enablers of compliance.
We deliver targeted training across GxP and ISO standards, adapted to roles and responsibilities. Our training focuses on practical application, regulatory intent, and real‑world scenarios based on inspector and assessor experience.
Strategic Alliances
Quality considerations are pivotal in pharmaceutical deals and organisational change. Early identification of quality and compliance risks safeguards asset value and supports a smoother, fully compliant integration.
Due Diligence (pre-deal)
In GxP‑focused due diligence, we support evaluation of the target’s compliance across clinical, manufacturing, laboratory, and distribution operations — assessing QMS maturity, inspection history, data integrity, and operational robustness to uncover risks that may affect product quality, patient safety, or regulatory acceptance.
Acquisitions
During the acquisition phase, we can help you with a plan for a smooth transition by identifying critical compliance gaps, reviewing quality agreements, and preparing integration steps across all GxP areas. After the deal closes, we facilitate aligning quality systems, oversight responsibilities, and processes with the acquiring party.
Partnership and Co-sponsorship
In partnerships and co‑sponsorships, we can ensure that all parties operate under aligned GxP standards by assessing system maturity, compliance history, and oversight capabilities. We can also support with change of sponsorship in clincal trials.