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Regulatory, Quality & Compliance

Helping your business achieve the optimum commercial outcome for your products

We can help you

We have a trusted history of success, managing over 160 projects each year, including the submission of 60 major applications to regulatory authorities. As such, we understand your unique needs and are perfectly positioned to optimise your business.

  • Regulatory due diligence and gap analysis
  • Dossier and technical file evaluation 
  • Competitive intelligence
  • Presubmission meetings
  • Resubmission strategies
  • Bioequivalence and clinical strategies
  • comparable overseas regulator (COR) pathways
  • ACCESS consortium pathways
  • Project orbis pathways
  • Priority review and abbreviated evaluation pathways
  • Provisional registration pathways
  • Technical file evaluation and compilation
  • Clinical evidence and design examination
  • Manufacturer’s evidence applications
  • Conformity assessment
  • Inclusion applications
  • Regulatory agency liaison
  • Portfolio lifecycle management
  • Dossier evaluation and compilation
  • Regulatory agency liaison
  • Submissions for:
    • New chemical entities
    • New biological entities
    • Generics, biosimilars and non-Biological complex generic medicines
    • Fixed dose combination products
    • Portfolio lifecycle management
  • Specialty applications including:
    • Literature based submissions
    • Orphan designations
    • Priority review and provisional determinations
    • Rescheduling applications
    • Appeals
    • Restricted representation and exemption methods
  • eCTD and NeeS electronic publishing
  • Creation of eCTD baselines
  • Portfolio lifecycle management
  • Ingredient/component and labelling assessments
  • Claims and instructions for use assessment
  • Regulatory agency liaison
  • Regulatory applications
  • Portfolio lifecycle management
  • Ingredient and labelling assessments
  • Claims assessment
  • AICIS/FSANZ/government liaison
  • Portfolio lifecycle management
  • GMP and technical agreement reviews
  • Batch release recommendations
  • Complaint handling
  • Medicines shortage notifications
  • Product quality reviews
  • Recall management, communication and support
  • Release for supply
  • Import and export licences



Clients across the globe


Major applications on average each year


Regulatory projects in the past 12 months