Services
Quality and Compliance
Complyomics approaches Quality as a Continuum.
Become full confident in your productive and effective Quality management:
- Compliant with global regulatory standards (GxP).
- Scalable across your company /product development.
- Built for long-term sustainability and audit readiness.
Design and deployment of Quality Management System (QMS).
Preparation of the QMS related documents (Quality Manual, SOPs, Site Master File, ...).
Inspection and Certification readiness.
Training (Quality Standard regulations, Audit conduct, SOP preparation, Bioanalytical / Analytical strategies, ...).
External Quality Assurance
To support organizations with an efficient and cost-effective QA function we propose
4 pre-defined External Quality Assurance packages:
For Start-up or small size biotech seeking to start theirQuality journey.
For organizations committed to Quality management aiming for advanced best practices,to be recognized as premium player.
For organizations required to comply with GxP regulations and wishing successful Regulatory Authorities inspections.
GxP regulations
and wishing successful Regulatory Authorities inspections.
For organizations with a temporary QA resource gap and needing immediate solution.
Bioanalytical Solutions
Our services span from non-regulated assay development to comprehensive GxP validation,
ensuring support for your GLP and GCP studies as well as GMP QC activities,
with a strong focus on Biotherapeutics.
We provide tailored training on specific topics:
GxP method validation, Assay trouble-shooting,
Assay formats for different biotherapeutic modalities.
Fit for purpose assay development and validation
Monitoring of assay robustness
Selection and qualification of CROs
Oversight of sample analysis
Quality Audits
We offer audits
- encompassing Systems, Facility, Processes, Computer System Validations (CSV) and Studies - aligned with GxP Standards such as:
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
Good Clinical Laboratory Practice (GCLP)
Good Documentation Practice, ALCOA+
Systematic, independent and documented audit process conducted by Certified Quality Auditor from American Society for Quality (ASQ).
