Enimera Regs+ has extensive Regulatory experience, supporting services across a range of product types.
Biologics and Biosimilar Medicines
Vitamins, Herbal and Mineral Supplements
- 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
- 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
- Productivity and Effectiveness
- Individual mentoring
- Team education and mentoring
- Team effectiveness checks