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//Ag Chem
Ag Chem2018-11-02T13:08:20+00:00

With a proven track record and long history of working in agrochemicals, RSA provides expert advice and support in gaining and maintaining registrations through bespoke safety science and regulatory expertise.

Study management
  • Management of international cross-functional project teams
  • Management of registration process (primarily EU) for:
    • new products
    • maintenance, label changes
    • re-registrations, Annex I renewals (AIR 1, AIR 2. AIR3 etc)
  • Study management, including
    • Study design and Study Monitoring
    • CRO liaison
    • report review and potential regulatory impact of results/conclusions.
  • Specialist areas include genetic toxicology, inhalation toxicology, reproductive and developmental toxicology, pathology, neurotoxicology, DMPK and environmental risk assessment, ecotoxicology and fate’. See our expertise page for details.
Literature reviews
  • Extended literature search, followed by review of relevance and reliability, and standardized reporting are an additional requirement of EU Regulation No 1107/2009, Article 8(5)
Dossier preparation
  • OECD summaries
  • CLH dossiers, annexes and IUCLID 6 submissions
  • Data gap analyses
  • Toxicology, metabolism, residues, environmental risk assessment, ecotoxicology and fate summary sections
  • Consumer risk assessments
  • Operator exposure assessments
Product maintenance/defence
  • Advocacy, liaison and representation with regulatory authorities – expert advice available for all major human health endpoints
    • Position paper preparation, rebuttals and waiver requests
    • Establishing mode of action (MOA) in animals and relevance to humans
    • Investigative toxicology and mechanistic problem solving
    • Review of data requirements, production of data gap analysis, study requirements and read-across potential for each endpoint
    • Critical regulatory competitor analysis and comparative assessment
    • New legislation advice / implications, for example, Regulation (EC) 1107/2009 ( ‘the 91/414 update’) or REACH, classification and labelling
    • Combined toxicity assessments for mixtures
    • Environmental risk assessments
    • Environmental Quality Standard (EQS) position papers
    • Preparation of OECD summaries
    • Ecotoxicology risk assessment
    • SAR analysis
Product positioning
  • Regulatory support to maximise product lifespan and develop opportunities