Trium Clinical Consulting
Consultancy and services organisation supporting life-science and medical device companies across the full product lifecycle. Offers regulatory affairs, clinical/CRO services, qualification & validation, quality assurance, GMP laboratory testing, software solutions (cloud QMS and eIFU), and business/commercialisation support. Operates internationally with multiple regional offices.
Industries
N/A
Nr. of Employees
small (1-50)
Products
Quality-by-Design support module for eQMS
A Quality‑by‑Design (QbD) focussed module integrated with a cloud-based eQMS to guide risk assessments, define cQAs/cPPs/cMAs, map processes and support risk-based process development and continuous process verification.
GMP laboratory analytical services (Quercus facility)
On-site GMP laboratory providing chemical analysis, microbiological analysis, stability studies and release testing aligned with ICH and GMP requirements.
Quality-by-Design support module for eQMS
A Quality‑by‑Design (QbD) focussed module integrated with a cloud-based eQMS to guide risk assessments, define cQAs/cPPs/cMAs, map processes and support risk-based process development and continuous process verification.
GMP laboratory analytical services (Quercus facility)
On-site GMP laboratory providing chemical analysis, microbiological analysis, stability studies and release testing aligned with ICH and GMP requirements.
Services
Strategic regulatory advice and operational support from classification through MAA/CTA submissions and post-approval activities for drugs, biologics, ATMPs, medical devices and IVDs.
Clinical study design and execution, CRO services specializing in devices and biotech, medical writing, data management, staffing and site/project management.
GMP-compliant QC laboratory testing including chemical analysis, microbiology, stability studies and release testing for raw materials and finished products.
Commissioning, equipment and facility qualification, process and cleaning validation, sterilization validation and analytical method validation.
QMS design and implementation, audit services, compliance specialists, QP and PRRC support, PQR services and toxicology advisory.
Deployment and validation of cloud-based pre-validated QMS platforms, eIFU/e-labeling solutions and computer system/software validation services.
Strategic regulatory advice and operational support from classification through MAA/CTA submissions and post-approval activities for drugs, biologics, ATMPs, medical devices and IVDs.
Clinical study design and execution, CRO services specializing in devices and biotech, medical writing, data management, staffing and site/project management.
GMP-compliant QC laboratory testing including chemical analysis, microbiology, stability studies and release testing for raw materials and finished products.
Commissioning, equipment and facility qualification, process and cleaning validation, sterilization validation and analytical method validation.
QMS design and implementation, audit services, compliance specialists, QP and PRRC support, PQR services and toxicology advisory.
Deployment and validation of cloud-based pre-validated QMS platforms, eIFU/e-labeling solutions and computer system/software validation services.
Expertise Areas
- Regulatory compliance and submissions (pharma, biotech, devices, IVD, ATMP)
- Clinical trial operations and CRO services
- Quality management systems (QMS) and audits
- GMP laboratory testing and QC
Key Technologies
- Cloud-based quality management software (eQMS)
- Computer system validation (CSV)
- eIFU / e-labeling systems
- Analytical method validation
News & Updates
Whitepaper covering pitfalls and best practices for establishing a new GMP facility.
Whitepaper guiding through regulatory documents and processes for clinical evaluation under MDR.
Whitepaper describing DTx regulatory and reimbursement pathways across multiple countries.
Whitepaper covering pitfalls and best practices for establishing a new GMP facility.
Whitepaper guiding through regulatory documents and processes for clinical evaluation under MDR.
Whitepaper describing DTx regulatory and reimbursement pathways across multiple countries.