https://en.bioecon.ru/clusters/regulatory-legal/Recent content in Regulatory-Legal on BioeconHugoen-USSun, 26 Jul 2026 00:23:48 +0700https://en.bioecon.ru/technology/fsma-haccp-certification-for-bio-food/Sat, 25 Jul 2026 17:10:00 +0000https://en.bioecon.ru/technology/fsma-haccp-certification-for-bio-food/Third-party audit, certification and testing that lets a food business prove its safety system works — FSMA Section 204 traceability with key data elements and critical tracking events, the FSSC 22000 Version 7 transition running to May 2027, HACCP preventive controls, and the laboratory verification underneath all of it.https://en.bioecon.ru/technology/novel-food-approval-as-a-service-eu-uk-sg/Sat, 25 Jul 2026 17:00:00 +0000https://en.bioecon.ru/technology/novel-food-approval-as-a-service-eu-uk-sg/Consultancies that carry a new food ingredient through pre-market authorisation — EFSA novel food dossiers, UK FSA filings that no longer follow the EU automatically, US GRAS notifications and Singapore submissions — a service defined by the fact that the same ingredient now needs separate dossiers per jurisdiction.https://en.bioecon.ru/technology/biopesticide-registration-fifra-eu-1107/Sat, 25 Jul 2026 13:24:41 +0000https://en.bioecon.ru/technology/biopesticide-registration-fifra-eu-1107/Specialized regulatory-consulting and GLP study services that guide biological and conventional crop-protection products through the US FIFRA/EPA biopesticide pathway (BPPD fast-track for microbial, biochemical and plant-incorporated protectants) and the EU Regulation (EC) No 1107/2009 zonal authorization (EFSA evaluation, Member-State approvals), assembling the efficacy, ecotoxicology, mammalian toxicology, environmental-fate and residue data packages that registration dossiers require — a multi-year, project-priced service whose demand is rising as the EU Farm to Fork targets a 50% pesticide reduction and growers shift to biological controls.https://en.bioecon.ru/technology/bio-substitution-consulting-petro-bio/Sun, 05 Jul 2026 00:00:00 +0000https://en.bioecon.ru/technology/bio-substitution-consulting-petro-bio/Market-intelligence and LCA consulting that screens which petrochemical building blocks can be feasibly swapped for bio-based drop-in equivalents, verifies renewable-carbon-share claims for regulators and brand customers, and models the cost-parity timeline against fossil incumbents.https://en.bioecon.ru/technology/gmp-consulting-nutraceuticals/Sun, 05 Jul 2026 00:00:00 +0000https://en.bioecon.ru/technology/gmp-consulting-nutraceuticals/Specialized consulting and third-party certification firms that prepare dietary-supplement and nutraceutical manufacturers to pass 21 CFR Part 111 and equivalent audits, covering botanical-identity testing, HVAC cleanroom design and QMS documentation.https://en.bioecon.ru/technology/port-biological-quarantine-as-a-service/Sun, 05 Jul 2026 00:00:00 +0000https://en.bioecon.ru/technology/port-biological-quarantine-as-a-service/LAMP isothermal DNA screening and DNA barcoding that identify quarantine pests from a wood shaving or larval fragment in 20-30 minutes, paired with UV/electrochlorination ballast water treatment systems and nitrogen eco-fumigation, letting ports clear cargo through phytosanitary and biosecurity checks without the week-long delays of classical methods.https://en.bioecon.ru/technology/regulatory-sandboxes-biotech/Sun, 05 Jul 2026 00:00:00 +0000https://en.bioecon.ru/technology/regulatory-sandboxes-biotech/Time- and space-bounded regulatory regimes that let biotech companies test breakthrough innovations — cultivated meat, unregistered cell therapies, novel-food bioprocesses — under direct regulator supervision before standard registration, cutting years off a 10-12-year approval timeline.https://en.bioecon.ru/technology/cmc-regulatory-consulting/Wed, 24 Jun 2026 00:00:00 +0000https://en.bioecon.ru/technology/cmc-regulatory-consulting/Specialized strategic advisory services guiding biopharma through the complex Chemistry, Manufacturing, and Controls (CMC) requirements to successfully file Biologics License Applications (BLA) and Marketing Authorisation Applications (MAA).