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Biosafety

3BIO provides expert biorisk management for the handling, storage, and disposal of biological materials, including pathogens, infectious agents, and genetically modified organisms. We integrate biosafety and biosecurity measures across containment levels BSL1 to BSL4, advise on infrastructure, equipment, and procedures, and ensure compliance with WHO Biosafety Manual, NIH Guidelines, CDC Guidelines, Canadian Biosafety Standards, and national regulations.

Our Services

Comprehensive Biosafety Solutions

From biorisk management through infrastructure design to compliance audits, we cover the full scope of your biosafety needs.

Biosafety management

Biorisk Management

Comprehensive biorisk management integrating biosafety and biosecurity to protect people, animals, and the environment from hazardous biological materials. Hands-on selection of cost-efficient measures across BSL1–BSL4 containment levels, referencing WHO Biosafety Manual, NIH Guidelines, CDC Guidelines, and Canadian Biosafety Standards.

  • • Biosafety & biosecurity integration
  • • BSL1 to BSL4 program development
  • • International & national standards compliance
Cloud platform technology

OrBios Platform

Coming Soon

Cloud-based platform (Organizing Biosafety) for centralized biorisk management. Tracks authorization expiry dates, equipment revalidation alerts, and all compliance deadlines, built on extensive expert experience with diverse activities.

  • • Centralized compliance dashboard
  • • Authorization & deadline tracking
  • • Equipment revalidation management
Professional biosafety officer

Biosafety Officers

External biosafety officer services fulfilling legal mandates. Acts as bioveiligheidscoördinator (Flanders) or bioveiligheidsverantwoordelijke / responsable de la biosécurité (Brussels & Walloon Region) for full implementation and oversight of biosafety protocols.

  • • External officer appointment
  • • Mandatory task completion
  • • Targeted project support
Lab infrastructure

Construction & Infrastructure

Integration of biosafety from the early conceptual phase through design, realization, validation, and commissioning of laboratories, production plants, animal facilities, clinical trial centers, and greenhouses. Bridges operational needs with construction realities to avoid costly retrofits.

  • • Technical requirements & material selection
  • • Installation verification & validation
  • • Facility commissioning
Data analysis charts

Risk Assessment

Identification of hazards and evaluation of likelihood and severity of harm using tailored methodologies. Supports selection of appropriate biosafety management measures and development of organization-specific risk assessment procedures.

  • • Hazard identification & evaluation
  • • Method selection & application
  • • Procedure development & implementation
Compliance audit

Audits

Compliance, performance, and system audits of biosafety management programs. Detailed audits follow ISO 35001:2019 and WHO Global Action Plan for Poliovirus Containment (GAP IV). Includes third-party containment-level verification and preparation for regulatory inspections.

  • • ISO 35001:2019 & GAP IV audits
  • • On-site & remote verification
  • • Self-inspection system setup
Training and education

Trainings

Tailored training programs for general staff, maintenance, lab/field personnel, project leaders, and biosafety officers. Covers biosafety cabinets, risk assessments, waste handling, emergencies & spills. Delivered on-site or web-based by experienced trainers.

  • • Role-specific & topic-specific modules
  • • On-site & web-based delivery
  • • Regulatory awareness & compliance
Legal documents

Permits

Full support for contained-use authorizations for GMOs and pathogens, including dossier compilation, submission, defence, and implementation of approval conditions. Also covers worker protection, quarantine, biobanks, animal by-products, biocides, and emergency planning.

  • • Contained-use dossier preparation
  • • Regulatory submission & follow-up
  • • Multi-framework compliance
Legal compliance scales

Compliance Analysis

Mapping of all applicable legislation for activities involving biological materials, including worker protection, quarantine, biobanks, animal by-products, biocides, and emergency planning. Extends to regulatory planning with mapped project timelines and required steps.

  • • Applicable regulation identification
  • • Gap analysis & risk mapping
  • • Regulatory planning & timelines
Our Approach

Early integration. Technical precision. Full compliance.

We engage from the planning phase to prevent costly modifications and regulatory gaps. Combining hands-on biorisk expertise with in-house knowledge of biotechnology regulatory and biodiversity (ABS/DSI) requirements, we deliver seamless support — from biorisk programs and external biosafety officers to contained-use permits and facility commissioning.

Ready to secure your biorisk management program?

From BSL1-BSL4 program development to ISO 35001 audits and contained-use authorizations, 3BIO delivers the technical precision and regulatory expertise your operations demand.

Contact Our Team
Related Services

Integrated Compliance Solutions

Biosafety excellence often requires coordination with adjacent regulatory domains. Explore our complementary services.

Biotech Regulatory

EFSA dossier preparation, Directive 2001/18/EC compliance, ERA, PMEM, and market authorization for GMOs, NGTs, novel foods, and biologicals. Seamlessly integrate biorisk management with your regulatory pathway.

Explore Biotech Regulatory →

Biodiversity & ABS Compliance

Navigate Nagoya Protocol, DSI & Cali Fund, and genetic resource access regulations. Ensure your biotech R&D sourcing is legally compliant and ethically sound from the outset.

Explore Biodiversity Services →
Frequently Asked Questions

Biosafety FAQs

Common questions about biosafety services, compliance requirements, and how we support your organization.

We provide comprehensive guidance across all biosafety levels (BSL1, BSL2, BSL3, and BSL4). Our biorisk management services follow WHO, NIH, and CDC guidelines to ensure your operations meet the highest safety standards regardless of the biological hazard level you work with.

OrBios is our cloud-based biorisk management platform designed to streamline and oversee all aspects of your biosafety compliance. It tracks deadlines, authorizations, equipment revalidation, and provides centralized management of your entire biorisk management system for enhanced efficiency and transparency.

Yes, we offer external biosafety officer services. In many countries, organizations are legally mandated to have a designated biosafety officer. Our team of experienced professionals can provide this critical role, ensuring your operations maintain full compliance with regulatory requirements and international best practices.

Absolutely. We specialize in integrating biosafety from the planning phase of laboratories, production plants, and clinical centers. This ensures optimal safety design, compliance with containment requirements, efficient operational workflows, and cost-effective implementation from the ground up.

We provide full dossier services for contained use authorizations, including approvals for GMOs and pathogenic organisms. Our team handles the complete permit application process, from hazard assessment through regulatory submission and approval, ensuring compliance with local, national, and EU requirements.

Ready to Strengthen Your Biosafety Management?

Schedule a technical consultation to discuss your biorisk management needs, containment requirements, and compliance objectives. Our team will provide a tailored approach for your facility.

Schedule a Technical Consultation

Want a deeper understanding of ISO 35001 biorisk management?

Read our in-depth guide with practical steps, key obligations, and expert insights.

Read the full guide →