Complyomics Sàrl is a consultancy supporting pharmaceutical, biotech/medtech organisations and contract research organisations (CROs) on quality and regulatory compliance. Services include design and deployment of quality management systems (QMS), externalised quality assurance, tailored bioanalytical solutions (assay development, GxP validation, GLP/GCP/GMP sample analysis), audits, due diligence and training.
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Industry:Management Consulting
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Design and deployment of Quality Management Systems (QMS)
Design and deployment of Quality Management Systems; creation of Quality Manual, SOPs and Site Master File; preparation for inspections and certifications; training on quality standards.
Outsourced Quality Assurance
Outsourced Quality Assurance functions as scalable packages for start-ups, biotech companies, GxP-regulated organisations and temporary QA resource gaps.
Bioanalytical solutions
Development and monitoring of analytical and bioanalytical strategies for biotherapeutics; assay development and validation, monitoring assay robustness, CRO selection and oversight of sample analysis.
Quality audits
Audits for systems, facilities, processes, CSV and studies; aligned with GLP, GMP, GCLP as well as Good Documentation Practice and ALCOA+.
Training and workshops
Training on quality standards and regulations, conducting audits, SOP drafting as well as bioanalytical and analytical strategies and methods validation.
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