Quality & Compliance Support

We provide comprehensive Quality, Compliance and Regulatory support to pharmaceutical, biotechnology, Life Sciences and healthcare organizations, helping them establish, maintain and continuously improve effective and inspection-ready Quality Management Systems. Our approach combines GMP and regulatory expertise, hands-on pharmaceutical experience and risk-based thinking. We work alongside Quality, Manufacturing, Engineering and Regulatory teams to translate complex requirements into practical processes, effective governance and sustainable ways of working. From the development of a new Pharmaceutical Quality System to the remediation of specific compliance gaps, ALLOVIS provides flexible support tailored to the size, maturity, products, technologies and regulatory environment of each organization. Pharmaceutical Quality Systems – QMS / PQS We support the design, implementation, assessment and optimization of Pharmaceutical Quality Systems (PQS) throughout the organization and product lifecycle. Our support can cover the complete QMS framework, including SOP and documentation systems, deviations, investigations, CAPA, Change Control, Quality Risk Management, complaints, supplier quality management, training, management review, quality metrics and continuous improvement. We can help organizations establish a new Quality System, review an existing one or harmonize processes across different sites, departments and business units. Particular attention is given to ensuring that Quality Systems are not only compliant on paper but effective in daily operations, with clear responsibilities, appropriate escalation mechanisms and processes capable of identifying, assessing and controlling quality risks. GMP Compliance & Regulatory Requirements We help clients understand, interpret and implement applicable GMP and GxP requirements across pharmaceutical operations. Our experts can support organizations in assessing their current compliance status, identifying gaps and developing risk-based remediation and improvement plans aligned with applicable regulatory expectations. Support can include areas such as EU GMP requirements, sterile manufacturing and Annex 1, computerized systems, Data Integrity, qualification and validation, contamination control, outsourced activities, supplier oversight and Good Distribution Practice, depending on the client's activities and regulatory environment. We also help organizations prepare for new or evolving regulatory requirements, evaluating their potential impact on facilities, processes, documentation and Quality Systems and translating regulatory changes into concrete implementation plans. Regulatory Support ALLOVIS provides regulatory support throughout different stages of the pharmaceutical and product lifecycle, helping organizations understand and manage the requirements applicable to their products, processes, facilities and markets. Our support can include regulatory gap assessments, regulatory strategy support, interpretation of applicable requirements, preparation and review of quality and technical documentation, change-impact assessments and support for interactions or preparation activities related to Health Authorities. Where specialist jurisdiction-specific regulatory expertise is required, we can work alongside the client's Regulatory Affairs function and relevant subject-matter experts to integrate Quality, GMP, technical and regulatory perspectives into a coordinated strategy. Quality Operations & Remediation Quality challenges often require more than strategic consulting. We can provide hands-on operational support when Quality organizations need additional expertise or capacity. Our specialists can support deviation and investigation management, root-cause analysis, CAPA development and effectiveness assessment, Change Control, risk assessments, documentation remediation and quality-process optimization. We can also support organizations following audit or inspection findings, helping evaluate observations, determine root causes, define appropriate remediation strategies and establish sustainable corrective and preventive actions. The objective is not simply to close individual findings, but to understand whether they indicate broader systemic weaknesses within the Quality System. Supplier & Outsourced Activity Quality Management Modern pharmaceutical operations rely on increasingly complex networks of suppliers, manufacturers, laboratories, distributors and service providers. We support the development and improvement of supplier qualification, Quality Agreements, supplier risk classification, performance monitoring, periodic evaluation and Quality oversight of outsourced activities. This support can extend across API and raw-material manufacturers, CMO/CDMOs, contract laboratories, packaging suppliers, equipment manufacturers, logistics providers and other critical GxP suppliers. Combined with our supplier audit capabilities, this enables ALLOVIS to support the complete supplier-quality lifecycle — from initial risk assessment and qualification through ongoing monitoring, auditing and periodic requalification. Data Integrity & Digital Quality Quality Systems increasingly depend on reliable data and digital processes. We support clients in strengthening Data Integrity governance and ALCOA+ principles across paper-based, hybrid and computerized environments. Our Quality expertise can be complemented by ALLOVIS' software, data and digital capabilities, supporting organizations in evaluating workflows, data flows and digital Quality processes and identifying opportunities to improve efficiency without compromising compliance. This also creates a foundation for the responsible introduction of digitalization, automation and AI-supported Quality processes within regulated environments. Quality Systems that work in practice Our Quality & Compliance services can support a wide range of organizations across the Life Sciences ecosystem, including pharmaceutical and biotechnology companies, API and drug-substance manufacturers, finished-product manufacturers, sterile manufacturing sites, ATMP organizations, CMO/CDMOs, contract laboratories, medical and pharmaceutical equipment suppliers, distributors, healthcare organizations and hospital pharmacies. Whether the objective is to build a Quality System from the ground up, prepare for growth, remediate compliance gaps, respond to regulatory observations, integrate a new facility or technology, or continuously improve an established PQS, our focus remains the same: creating Quality Systems that are compliant, pragmatic and sustainable.