Regulatory & certification

Chlorella, spirulina and specialist microalgae strains are processed into functional protein isolates and pigmented ingredients for bakery goods, meat analogues and nutraceuticals — distinct from the aquafeed-focused microalgae industry built around omega-3 lipids.

Software platforms and data providers that classify controlled biotech and life-science goods, screen counterparties against denied-party and sanctions lists, and trace ownership and supply-chain networks so dual-use…

How a bio-claim is made provable: ISCC PLUS supply-chain certification on top of mass-balance production, ASTM D6866 radiocarbon measurement of biogenic carbon, and the digital product passport regime the EU adopted in July 2026 to keep such claims travelling with the product.

The certification apparatus that decides whether a material can be called compostable: EN 13432 and ASTM D6400 conformance, the Seedling scheme whose 2026 revision tightens evidence for minor components,…

Specialist consulting and GLP-study services that take biological and conventional crop-protection products through the US FIFRA/EPA biopesticide pathway (the BPPD fast track for microbial, biochemical and…

Physical-containment infrastructure — biosafety cabinets, HEPA filtration, autoclave sterilization and BSL-1 through BSL-4 containment — protecting personnel, product and environment in every biotech lab, to NSF/ANSI 49 and EN 12469.

Specialist strategic-consulting services that guide biopharmaceutical companies through the complex chemistry, manufacturing and controls (CMC) requirements for a successful licensing submission (BLA/MAA).

Independent certification services that verify both organic origin (EU 2018/848, USDA NOP, GB/T 19630) and bio-based carbon content (ASTM D6866), letting brands combine a natural-origin claim with a measured bio-percentage on a single label.

Cas-enzyme nucleic-acid detection — bedside-to-strip molecular diagnostics from sample to paper strip.

Independent auditing firms that check pharmaceutical, biologics and cosmetics distributors and wholesalers against Good Distribution Practice (GDP) and supplier-qualification standards, giving a manufacturer…

Screening every DNA and RNA synthesis order against a curated database of hazardous pathogen and toxin sequences before manufacturing.

Regulatory consulting firms that prepare and submit the safety dossiers a feed-additive manufacturer needs to sell in the EU (EFSA FEEDAP Panel review under Regulation (EC) No 1831/2003) or the US (FDA GRAS notification…

B2B food biopolymers — modified starches, plant-protein isolates and hydrocolloids — via reactive extrusion, wet fractionation and isopropanol precipitation, for texture, structure and clean-label formulation in the food industry.

Third-party audit, certification and testing that let a food operation prove its safety system works: FSMA Section 204 traceability with key data elements and critical tracking events, the move to FSSC 22000 version 7…

Specialist third-party consulting and certification firms that prepare dietary-supplement and nutraceutical manufacturers for 21 CFR Part 111 and equivalent standard audits, covering botanical raw-material authenticity testing, cleanroom HVAC design and QMS documentation.

Religious-authority audit and certification bodies that determine whether a fermentation-derived enzyme, cultivated cell-based protein or other bio-based ingredient meets halal or kosher requirements.

Preparing the clinical and scientific evidence dossier that substantiates a health claim under the EFSA Article 13/14 framework.

Specialist research organizations that build the economic and clinical-outcomes evidence pharmaceutical and biotech companies need to justify product value to payers and health-technology assessment (HTA) bodies.

Health-economic evidence packages — systematic reviews of clinical data, cost-effectiveness and budget-impact modelling, patient-perspective…

The UN high-seas treaty (BBNJ Agreement) entered into force in January 2026, creating the first legal regime for access to, and benefit-sharing from, marine genetic resources beyond any state's waters.

Consulting firms that secure CPT/HCPCS billing codes, payer coverage policies and national health-insurance listings for medical devices.

Regulatory affairs firms that register consumer-facing bio-products — novel foods, cosmetics, food-contact materials and new ingredients.

Regulatory consulting firms and eCTD submission software that manage biopharmaceutical registrations simultaneously across the FDA, EMA, China's NMPA and Japan's PMDA.

Consultants who take a novel food ingredient through pre-market authorization — a novel food dossier for EFSA, submissions to the UK FSA (which no longer automatically follows the EU), US GRAS notifications, and…

Market intelligence and LCA consulting that screens which petrochemical building blocks can be technically replaced by bio-based drop-in equivalents, verifies renewable-carbon-content claims for regulators and brand…

Point-of-care molecular diagnostics run nucleic-acid testing outside the central lab — in a clinic, emergency department or field site — delivering an on-site result without sending samples away.

Port biological quarantine combines rapid molecular diagnostics for regulated organisms with environmentally sound cargo treatment, letting ships and containers clear phytosanitary and biosecurity checks without the long delays of classical methods.

Regulatory consulting firms and regulatory-monitoring software that register, classify and track bio-based chemicals under the EU REACH regulation.

Software platforms that continuously track global changes in drug and biologics regulatory requirements — guideline updates, substance-list changes, post-approval change triggers.

Flexible, time- and scope-limited regulatory regimes that let biotech companies test breakthrough innovations — cultivated meat, unapproved cell therapies, novel-food bioprocesses.

Eye-scanning technologies that detect Alzheimer's and other neurodegenerative disease biomarkers directly in the retina — a window onto brain pathology accessible without imaging the brain itself.

Metagenomic sequencing platforms that assess soil microbiome composition and function, generating standardized soil-health passports used to verify carbon-credit claims, guide biological-input decisions and comply with…

Technical committees and certification bodies — developing the terminology, life-cycle-assessment and mass-balance rules that underpin every bio-content and sustainability claim in the bioeconomy.

Independent supply-chain auditing against the FSC, PEFC and RSB forestry and biomass standards, distinct from the standard-setting bodies themselves.