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PRODUCTS

Enimera Regs+ has extensive Regulatory experience, supporting services across a range of product types.

Novel therapeutics

Medicinal Cannabis

Biologics and Biosimilar Medicines

Generic Medicines

Medical Technologies

Vitamins, Herbal and Mineral Supplements

Online Learning

  • The Enimera RegsPlus Learner Module for aspiring and early-mid career Regulatory professionals
  • The Enimera RegsPlus Leader Module for aspiring and early-mid career Regulatory Managers

Translational Research

  • Education and Mentoring
    • Understanding the Pharma/Biotech industry
    • Mentoring and industry readiness programs

Commercialisation

Effectiveness and Productivity

  • Education and Mentoring
    • Education across the Scientific Affairs Disciplines, including leader development
    • On-site and remote (on-line tutorials)
    • Mentoring programs
  • Stakeholder Engagement and Policy
    • Development of strategic advocacy plans
    • Facilitating input to consultation documents
  • Regulatory Strategy
    • Development of Regulatory Strategies
    • Leading TGA and Medsafe meeting efforts
    • TGA Appeals an FOI requests
  • Regulatory Applications
    • Preparation of and/or review of
  • Project Management
    • Medicine Shortages
    • Other projects as defined
  • Pharmacovigilance
    • QPPVA role
  • Productivity and Effectiveness
    • Individual mentoring
    • Team education and mentoring
    • Team effectiveness checks