Regulatory & legal services

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.

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).

Third-party audit firms that inspect pharmaceutical, biologic and cosmetic distributors and wholesalers against Good Distribution Practice (GDP) and supplier-qualification standards, giving a manufacturer independent assurance that its downstream supply-chain partners handle products to specification.

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.

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.

Regulatory-affairs consultancies and eCTD submission software that manage biopharmaceutical filings across the FDA, EMA, China's NMPA and Japan's PMDA simultaneously — helping a biologics or biotech developer sequence and harmonize approvals across the world's major drug-regulatory jurisdictions.

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.

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.

Regulatory consultancies and compliance-intelligence software that register, classify and monitor bio-based chemicals under the EU's REACH regulation — registration dossiers, Only Representative services, and multi-jurisdiction chemical-regulatory monitoring for producers exporting into the EU.

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.

Software platforms that continuously monitor global drug and biologics regulatory changes — guidance updates, Candidate List additions, post-approval variation triggers — and use AI to filter and prioritize which changes affect a specific biopharmaceutical product portfolio.

TNFD disclosures and nature-related accounting transition traditional finance toward double materiality, utilizing GIS mapping and AI to quantify corporate dependencies on ecosystem services and mitigate biodiversity risks.