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Plan your next regulatory study

We will identify the endpoints, guidelines and specialist divisions your project requires — and advise you clearly on which studies are necessary.

Sectors
3
Stages
07
Divisions
7

Dossiers written for

16frameworks & authorities

  • OECD
  • CIBRC
  • EPA
  • EFSA
  • REACH
  • RoHS
  • CLP
  • GHS
  • California Proposition 65
  • SVHC
  • CE marking
  • GLP
  • FSSAI
  • Codex
  • ISO
  • International food standards

The working method

What happens between your first call and your report.

We start from the authority that will read the dossier, not from a study list. Divisions run in parallel wherever the science allows, and the record stays unbroken from receipt through to the tenth year of archival.

How the quality system governs it
  1. 01

    Scope

    We start from the authority that will read the dossier, not from the study list. The endpoints, guidelines and species follow from that decision.

    Regulatory strategy · guideline mapping · study design

  2. 02

    Receipt

    Test items enter through a controlled Test Item Control Office with separate storage zones for pharmaceutical and non-pharmaceutical products. Sponsors receive confirmation within 48 hours.

    TSC / TICO · segregated storage · 48-hour receipt

  3. 03

    Characterise

    Identity, purity, concentration and stability are established in chemistry before a dose is prepared. Every number generated downstream depends on this step being right.

    Identity · purity · stability guidance

  4. 04

    Conduct

    Studies run in accredited facilities with continuous in-life monitoring and veterinary oversight. Divisions run in parallel where the science allows, which is where the timeline is actually won.

    GLP conduct · in-life monitoring · parallel divisions

  5. 05

    Audit

    An independent Quality Assurance unit audits the study against the protocol and the GLP principles. QA reports to management, not to the study director.

    Independent QA · protocol compliance · phase inspection

  6. 06

    Report

    Data are compiled into a study report written for the submitting authority, with the raw data traceable from every conclusion back to the instrument that produced it.

    Traceable reporting · regulatory format

  7. 07

    Archive

    Raw data, specimens and reports are held for ten years with redundant backup on RAID servers, on-site and off-site.

    10-year archive · on-site and off-site redundancy

Sectors served

Three regulatory worlds, one evidence base.

The endpoints, guidelines and species in a programme follow from the authority that has to approve it. These three are the contexts the laboratory is built to write for.

Still life on a warm white bench: a labelled amber sample bottle beside a rack of capped clear vials, a shallow glass dish holding seed and a single leaf, in daylight.

02

Industrial Chemicals

Driving industrial progress with quality and compliance at the forefront.

REACH, RoHS, CLP, GHS and California Proposition 65 compliance data.

Written for

  • REACH
  • RoHS
  • CLP
  • GHS
  • California Proposition 65
  • SVHC
  • CE marking

Divisions carrying the work

03

Food & Feed Additives

Safeguarding food integrity and enhancing nutritional value for a healthier world.

Nutritional, microbiological, allergen and contaminant analysis with shelf-life support.

Written for

  • GLP
  • FSSAI
  • Codex
  • ISO
  • International food standards

Divisions carrying the work

Where to start

Assembled programmes, or a protocol of your own.

3 study packages are already mapped to the guidelines they satisfy. Where no guideline fits, custom study design runs inside the same GLP quality system as everything else.

Pre-assembled study packages

01Agrochemical Registration Dossier
Crop protection & fertiliser registrants
02REACH & Chemical Compliance
Industrial chemical manufacturers & importers
03Food & Feed Safety Panel
Food, feed & nutraceutical manufacturers

Start a programme

Plan your next regulatory study.

We will identify the endpoints, guidelines and specialist divisions your project requires — and advise you clearly on which studies are necessary.