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//Pharma
Pharma2018-11-02T13:08:20+00:00

With a collective experience of decades in the pharmaceutical industry, RSA’s Associates can provide all the advice you need to accelerate the progress of new drug candidates through development and on to the market, together with maintenance of registered products.

Study management
  • Management of international cross-functional project teams
  • Study management, including
    • Study design, program design, placement and Study Monitoring
    • CRO liaison
    • expert interpretation
    • 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 and target assessments
  • Extended literature search, followed by review of relevance and reliability, and standardized reporting
    • Target safety evaluations (tox liability)
  • PNEC assessments and environmental/data quality reviews
Dossier preparation
  • Non-clinical sections for IND, NDA, CTA applications and IB contributions
  • Study summaries and CTD tables
Product maintenance/defence
  • Preparing for scientific advisory meetings
  • Establishing mode of action (MOA) in animals and relevance to humans
  • Investigative toxicology and mechanistic problem solving
  • Authoring scientific publications and position papers
Product positioning
  • Regulatory support to maximise product lifespan and develop opportunities