We provide the following regulatory services:
Medicines (prescription, OTC, complementary, biological)
- Regulatory strategy advice
- Generic strategy advice
- Dossier review / gap analysis
- Presubmission support
- Dossier publishing (eCTD or NeeS)
- Standard or COR registration applications (e.g. NCE, FDC, major variations)
- Minor variation applications
- Other post approval maintenance activities
Medical devices (including diagnostics and software)
- Technical file review / gap analysis
- Technical file preparation
- Risk analysis
- Clinical evaluation reports (CERs)
- Conformity assessment applications
- Product registration
- Post approval maintenance
Cosmetics
- Ingredient assessment (AICIS, GHS, ACCC, etc.)
- Claims assessment
- Label assessment
Specialty applications
- Literature based submission (LBS)
- Priority review determination
- Provisional determination
- Orphan designation
- Rescheduling application
- Restricted representation application
Other support
- Local sponsorship
- Disinfectants and sterilants
- Sunscreens
- Other Therapeutic Goods (OTGs)
- Vet products
- Food products