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.
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.
Targeted Biosafety Coaching
At BioPrecis, we provide specialized biosafety and environmental consulting services for laboratories, research institutions, and biotech companies in and around Sofia. 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.
- Biosafety risk management
- Biobanking
- Environmental impact consulting
- Biosafety training
Environmental Impact
BioPrecis provides specialized environmental impact consulting to help organizations assess, manage, and mitigate the ecological consequences of their operations. We specialize in translating complex regulatory requirements into actionable strategies for PFAS detection, destruction, and functional substitution.
Biosafety 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.
Post-Implementation Auditing
BioPrecis ensures that your facility doesn't just reach compliance, but sustains it. Our auditing services focus on two critical pillars:
- Compliance & Regulatory Verification: We ensure continued adherence to WHO LBM4, ISO 35001, and CWA 15793 standards, as well as specific EU regulations such as the Nagoya Protocol (EU Regulation 511/2014) and Directive 2010/63/EU .
- Operational Effectiveness & Quality Control: We validate that laboratory infrastructure and equipment selection continue to meet risk-based criteria for containment and verification, ensuring your daily operations are safe, efficient, and robust.