Portofolio

We provide specialized biosafety and environmental consulting services for laboratories, research institutions, and biotech companies in Europe. We offer expert coaching to help organizations implement robust biosafety practices, comply with regulations, and minimize environmental risks. Our tailored guidance supports teams in building a strong safety culture and improving day-to-day operational standards.

DOWNLOAD full offering

Biosafety risk management

  • Risk‑based biosafety assessments aligned to WHO LBM4 and local EU implementation, covering GMOs, pathogens, and human body materials.

  • Biosafety program design and build: gap assessment, implementation plan, competency‑based training, and monitoring under LBM3/4 frameworks.

  • Laboratory design, commissioning, infrastructure, and equipment selection using risk‑based criteria for containment and verification.

  • Biorisk management system design and training based on ISO 35001 and CWA 15793, including QMS structure, risk registers, and PDCA cycles.

  • Access and benefit‑sharing due diligence and policy setup for Nagoya Protocol compliance under EU Regulation 511/2014.

Training Offer

  • Biosafety training workshops - incidents and accidents

  • Contained use of GM microorganisms and human tissues: classification, notifications, documentation, and incident response

  • Human tissues and cells governance: consent, traceability, vigilance, and deviation management

  • Directive 2010/63/EU compliance in practice: project authorization, severity classification, retrospective assessment, and AWB operations

Bibanking

  • Biobank QMS design, gap assessment, and ISO 20387 accreditation readiness covering competence, impartiality, and consistent operation.

  • BBMRI‑ERIC quality self‑assessment, internal audits, and preparation for BBMRI‑ERIC Quality Label and audit programs.

  • Human tissues and cells governance under Directive 2004/23/EC: consent, traceability, vigilance, and deviation management frameworks.

Environmental Impact

Environmental impact consulting helps organizations assess, manage, and reduce the environmental consequences of their projects and operations while ensuring compliance with relevant regulations.