Biovalorem
Professional services consultancy for life sciences that provides project and program management, quality systems, GxP-compliant IT, vendor management, data protection, and audit services. The firm integrates project management discipline, Lean Six Sigma, and regulatory-focused approaches to support clinical, non-clinical, manufacturing and IT activities across product development and commercialization.
Industries
Nr. of Employees
small (1-50)
Products
Regulatory Compliance Services
Services to support regulatory compliance in life science product development and manufacturing.
Project and Program Management
Management of projects and programs in research and manufacturing within life sciences.
Risk-Based Vendor Management Platform
A platform providing risk-based management of vendors for life science organizations.
Tactical GXP Auditing Services
Auditing services focused on GXP compliance for life science companies.
Regulatory Compliance Services
Services to support regulatory compliance in life science product development and manufacturing.
Project and Program Management
Management of projects and programs in research and manufacturing within life sciences.
Risk-Based Vendor Management Platform
A platform providing risk-based management of vendors for life science organizations.
Tactical GXP Auditing Services
Auditing services focused on GXP compliance for life science companies.
Services
Project, program and portfolio management for life-science initiatives, integrating earned value management, collaborative technologies and Lean Six Sigma.
Quality system design and QMS implementation, GxP audits (vendor, investigator site, internal), due diligence, inspection preparation and training.
Risk-based vendor management services including contract and quality agreement frameworks, qualification, routine and for-cause audits, and vendor performance monitoring.
Implementation and validation of GxP-compliant IT systems (document management, training management, eCRF/eCOA, CTMS, DCS/PLCs, electronic signatures), aligned with GAMP5-style approaches.
Tailored data-protection programs for life sciences, including data protection impact assessments, breach response, data transfer agreements and privacy-compliance advisory.
Project, program and portfolio management for life-science initiatives, integrating earned value management, collaborative technologies and Lean Six Sigma.
Quality system design and QMS implementation, GxP audits (vendor, investigator site, internal), due diligence, inspection preparation and training.
Risk-based vendor management services including contract and quality agreement frameworks, qualification, routine and for-cause audits, and vendor performance monitoring.
Implementation and validation of GxP-compliant IT systems (document management, training management, eCRF/eCOA, CTMS, DCS/PLCs, electronic signatures), aligned with GAMP5-style approaches.
Tailored data-protection programs for life sciences, including data protection impact assessments, breach response, data transfer agreements and privacy-compliance advisory.
Expertise Areas
- Clinical trial management and site monitoring
- Pharmacovigilance and patient safety
- Quality management systems (QMS)
- Vendor management and supply-chain compliance
Key Technologies
- GxP compliance frameworks (GAMP5-aligned validation)
- Distributed Control Systems (DCS)
- Programmable Logic Controllers (PLCs)
- Electronic Data Capture (eCRF / eCOA)
News & Updates
Published resource on standardizing patient risk and safety management practices.
Case study on pharmacovigilance operational practices.
Article addressing schedule management in DCS validation projects for pharmaceuticals.
Article on applying Lean Six Sigma in pharmaceutical projects to reduce defects.
Framework document for documentation management expectations in DCS validation.
Published resource on standardizing patient risk and safety management practices.
Case study on pharmacovigilance operational practices.
Article addressing schedule management in DCS validation projects for pharmaceuticals.
Article on applying Lean Six Sigma in pharmaceutical projects to reduce defects.
Framework document for documentation management expectations in DCS validation.