Our services

Biosafety, Biosecurity and Regulatory Compliance Support

We can help lab personnel in drafting the right biosafety, biosecurity and biocontainment procedures and records adapted to their needs, from CL2 to CL4:

• Biosafety Officer contractant

• Biosafety Manuals

• Training Programs

• Emergency Response Plans

• Risk Assessments

• Biosecurity

• Work Practices & SOPs

• Internal Audits

• Medical Surveillance Plans

• PPE selection

• Biomedical waste decontamination

• Autoclave Validation & Verification

• Records & Documentation

• National & International Regulatory Support

  • WHO laboratory biosafety manual, 4th ed.

  • Canadian Biosafety Standard, 3rd ed.

  • CDC Biosafety in Microbiological and Biomedical Laboratories 6th ed.

  • ISO 35001:2019—Biorisk management

• Laboratory Design & Space Optimization: Expert planning and layout of laboratory spaces to maximize efficiency and functionality.

• Equipment Selection & Procurement: Guidance on selecting the most suitable laboratory and support equipment, ensuring optimal performance and value.

• Manufacturer Liaison & Compliance: Collaboration with equipment manufacturers to guarantee specifications are met and standards are upheld.

• Value-Driven Equipment Optimization: Ensuring cost-effective equipment selection without compromising quality or performance.

• Installation, Operational & Performance Qualifications (IQ/OQ/PQ): Comprehensive qualification services for lab support and laboratory equipment to verify functionality and compliance.

• Physical Requirements Assessment: Interpretation of physical and technical specifications to meet laboratory operational needs.

• Greening Initiatives: Implementation of sustainable and eco-friendly practices to reduce environmental impact.

• Commissioning & Validation: Rigorous testing and commissioning of laboratory systems and equipment to ensure reliable operation.

• Breathing Air System Design & Testing: Custom design and thorough testing of breathing air systems for lab safety and compliance.

• Chemical Shower Design & Function: Engineering and validation of chemical shower systems to meet safety standards.

• Testing & Validation Plans: Development of detailed testing protocols to confirm equipment and system performance.

• Failure Mode & Effects Analysis (FMEA): In-depth risk assessment to identify and mitigate potential failures in laboratory systems and equipment.

• Structure and responsibilities

• Development of operation workflow,

• Financial planning

• Adapted, efficient and resilient reporting structure,

• Continuity Planning

• Strategic management and investment for long-term operation

• Outbreak Preparedness and Response

  
  

Engineering Solutions and Maintenance

Operations

Operations: Animal care

• Animal Facility design for workflow, layout, and finishes.

• Animal Facility Equipment selection (caging, imaging, downdraft and biosafety cabinet ergonomics as related to safe animal handling)

• Animal Husbandry SOP development/evaluation including processes for ingress/egress of animals, caging, and supplies.

• Veterinary Clinical Care SOP development/evaluation

• Safe animal sample/data collection process development.