# 3BIO â Unlocking Biological Resources, Safeguarding R&D Integrity > 3BIO is the integrated regulatory consultancy at the intersection of biodiversity, biosafety, and biotechnology. Based in Ghent, Belgium, we help biotech companies, pharmaceutical developers, agricultural innovators, and research institutions navigate complex legal frameworks across three interconnected domains. 3BIO is the only consultancy integrating biosafety, biodiversity governance, and biotech regulatory strategy under one roof. The team of 18 multidisciplinary professionals brings expertise from biology, genetics, environmental science, law, policy, and business. Legal entities: ABSint BV (BE0672.839.114) and Perseus BV (BE0480.089.325). Address: Kerkstraat 108, B-9050 Ghent, Belgium. Contact: info@3bio.eu, +32 (0)468 32 22 80. ## Core pages - [Why 3BIO](https://www.3bio.eu/why-3bio): What distinguishes 3BIO â integration of biodiversity, biosafety, and biotech regulatory expertise under a single consultancy. - [Industries](https://www.3bio.eu/industries): Sector-specific compliance for pharmaceuticals, animal and plant breeding, green and industrial biotech, cosmetics, fragrances, and food. - [About 3BIO](https://www.3bio.eu/about-3bio): Team, history, and the ABSint BV / Perseus BV corporate structure. - [Contact](https://www.3bio.eu/contact): Office in Ghent, Belgium. ## Biodiversity (ABS, Nagoya Protocol, DSI, ITPGRFA, BBNJ) - [Biodiversity overview](https://www.3bio.eu/biodiversity): Access and Benefit Sharing compliance for utilisation of genetic resources, Digital Sequence Information, and associated traditional knowledge. - [Nagoya Protocol Compliance](https://www.3bio.eu/biodiversity#nagoya): Due diligence under the Nagoya Protocol and the EU ABS Regulation; PIC and MAT obligations; tracing utilisation through the R&D value chain. - [ABS Trainings](https://www.3bio.eu/biodiversity#abs-trainings): Tailored training for R&D, procurement, and legal teams on ABS obligations. - [ABS Audits](https://www.3bio.eu/biodiversity#abs-audits): Internal audits of ABS compliance status, supply chain due diligence, and documentation gaps prior to regulatory inspection. - [ABS Permits & Agreements](https://www.3bio.eu/biodiversity#abs-permits): Drafting and negotiating PIC, MAT, and benefit-sharing agreements with provider countries. - [ABS Portal & Wizard](https://www.3bio.eu/biodiversity#abs-tools): Proprietary curated database of national ABS laws, with a wizard for rapid analysis of obligations by source country and utilisation type. - [Other ABS instruments](https://www.3bio.eu/biodiversity#other-abs-instruments): Digital Sequence Information (DSI), the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), and Biodiversity Beyond National Jurisdiction (BBNJ / High Seas Treaty, adopted 2023). - [ABS E-Learning](https://abs-elearning.com): Online training platform on ABS and the Nagoya Protocol. ## Biosafety (biorisk management, contained use, GMO handling) - [Biosafety overview](https://www.3bio.eu/biosafety): Identification and management of risks associated with biological agents and GMOs, aligned with WHO, NIH, CDC, and ISO 35001:2019 standards. - [Biorisk Management](https://www.3bio.eu/biosafety#biorisk-management): Systems for BSL1 through BSL4 facilities, aligned with WHO GAP IV and ISO 35001:2019. - [Biosafety Officers](https://www.3bio.eu/biosafety#biosafety-officers): Outsourced or embedded Biosafety Officer services for organisations without internal capacity. - [Biosafety Construction & Infrastructure](https://www.3bio.eu/biosafety#construction): Design review and commissioning support for containment facilities. - [Risk Assessment](https://www.3bio.eu/biosafety#risk-assessment): Activity-based risk assessments for contained use of GMOs and pathogens. - [Biosafety Audits](https://www.3bio.eu/biosafety#audits): Gap analyses against national contained-use legislation, ISO 35001:2019, and WHO GAP IV. - [Biosafety Trainings](https://www.3bio.eu/biosafety#trainings): Role-based on-site and web-based training for lab staff, principal investigators, and management. - [Biosafety Permits](https://www.3bio.eu/biosafety#permits): Compilation and submission of notifications and authorisations for contained use of GMOs. - [Compliance Analysis](https://www.3bio.eu/biosafety#compliance-analysis): Assessment of regulatory and standards compliance for biosafety operations. - [OrBios](https://www.3bio.eu/biosafety#orbios): Cloud platform for tracking biorisk deadlines, authorisations, and equipment revalidation. ## Biotech Regulatory (GMO, EFSA, market authorisation) - [Biotech Regulatory overview](https://www.3bio.eu/biotech-regulatory): End-to-end regulatory strategy and submissions for GMO products and novel biotechnologies, with an EU focus. - [Regulatory Analysis](https://www.3bio.eu/biotech-regulatory#regulatory-analysis): Classification of products under EU GMO, novel food, plant reproductive material, and NGT frameworks. - [Regulatory Policy](https://www.3bio.eu/biotech-regulatory#regulatory-policy): Engagement with evolving EU policy on New Genomic Techniques (NGTs), gene drives, and synthetic biology. - [Regulatory Strategy](https://www.3bio.eu/biotech-regulatory#regulatory-strategy): Pre-submission strategy, EFSA pre-submission engagement, study design, and stakeholder engagement to de-risk authorisation pathways. - [Regulatory Studies](https://www.3bio.eu/biotech-regulatory#regulatory-studies): EFSA-specific study design and oversight covering molecular characterisation, environmental risk assessment, and safety studies. - [GMO Development Trials](https://www.3bio.eu/biotech-regulatory#gmo-development): Authorisation of clinical, veterinary, and field trials with GMOs under Directive 2001/18/EC. - [Market Authorization](https://www.3bio.eu/biotech-regulatory#market-authorization): Dossiers for GM food and feed, GM medicinal products, novel food, and biologicals. - [Post-Market Compliance](https://www.3bio.eu/biotech-regulatory#post-market): Monitoring plans, renewal dossiers, and post-market environmental monitoring. - [Stewardship](https://www.3bio.eu/biotech-regulatory#stewardship): Product stewardship programmes including Excellence Through Stewardship (ETS) and Plant Biotechnology Industry (PBI) frameworks. ## Industries Served - [Pharmaceuticals](https://www.3bio.eu/industries#pharmaceuticals): Drug development, gene therapy, natural product sourcing, biosafety, ABS compliance. - [Animal Breeding](https://www.3bio.eu/industries#animal-breeding): Genetic improvement programmes, biosafety for breeding facilities, regulatory compliance for GMO animals. - [Plant Breeding](https://www.3bio.eu/industries#plant-breeding): Crop improvement, GM crops, NGTs, ITPGRFA compliance, field trials, stewardship. - [Green Biotech](https://www.3bio.eu/industries#green-biotech): Environmental biotechnology, bioremediation, biofuels, sustainability applications. - [Industrial Biotech](https://www.3bio.eu/industries#industrial-biotech): Enzymes, bio-based chemicals, fermentation, industrial-scale biosafety, genetic resource compliance. - [Cosmetics](https://www.3bio.eu/industries#cosmetics): Natural ingredient sourcing, ABS compliance for cosmetic ingredients, Nagoya Protocol compliance. - [Fragrances](https://www.3bio.eu/industries#fragrances): Fragrance ingredient sourcing from biological resources, ABS compliance, supply chain due diligence. - [Food](https://www.3bio.eu/industries#food): Novel food authorisation, food-grade biotechnology, genetic resource compliance for food ingredients. ## Research - [Research overview](https://www.3bio.eu/research): EU-funded research projects on biodiversity, biosafety, and biotech regulation, covering policy and regulatory research, stakeholder engagement, valorisation and sustainability, and communication and dissemination. - [Ongoing projects](https://www.3bio.eu/research-ongoing): Active research collaborations including BlueRemediomics (Horizon Europe, marine microbial biodiscovery), Marbles (Horizon 2020, marine genetic resources), NYMPHE (Horizon 2020, bioremediation), HOTBIO (Marie Curie ITN, marine natural products), and EATFISH (Marie Curie ITN, fish genetic resources). - [Completed projects](https://www.3bio.eu/research-completed): Past projects and deliverables. - [Publications](https://www.3bio.eu/research-publications): Peer-reviewed publications and policy contributions. ## Key regulatory frameworks - Nagoya Protocol on Access and Benefit Sharing - Convention on Biological Diversity (CBD) - EU Directive 2001/18/EC on the deliberate release of GMOs - ITPGRFA (International Treaty on Plant Genetic Resources for Food and Agriculture) - BBNJ Agreement (High Seas Treaty, adopted 2023) - EFSA guidance and EU pre-submission requirements - ISO 35001:2019 (biorisk management) - WHO Laboratory Biosafety Manual and GAP IV - CSRD and CSDDD (EU corporate sustainability reporting and due diligence)