Regulatory Affairs Consulting
Australian regulatory affairs consulting – drug development, due diligence, dossier reviews, general advise, registrations and submission support:
Liaison with the Regulatory Authorities – TGA and Medsafe
New Chemical & Biological Entity, Biosimilars, line extensions, major variations, Orphan Drugs (designation applications, registration applications), variations and general maintenance & general maintenance including literature based submissions.
New entities, Biosimilars, line extensions, major variations & general maintenance.
New generics, bioequivalence study management & general maintenance.
New Medicine Applications, New Generic Applications, clone applications, Switching Applications, variations and general maintenance.
Medical Devices (Class I- III)
Documentation advise for inclusion, inclusion submission steps
Literature Based submissions
Literature search strategy development, pre-submission activities with TGA, literature sourcing and translations, pre-clinical &medical writing, dossier finalisation, dossier submission.
Dossier review-gap analysis reports
Review of dossier in accordance with Australian & New Zealand guidelines for registration.
Pre-Submission meetings and Liaison with the Authorities
In Australia assistance with Priority Review/Designation, Provisional Registration and Comparable Overseas Regulator (COR) pathway. In New Zealand assistance with Priority and Abbreviated pathway options.
GMP matters (Licensing, clearances)
Assistance in arranging TGA GMP Inspections, TGA GMP inspection readiness, GMP Pre-Clearance activities
Clinical Trial support
EC submission packages, CTN coordination and submission, clinical project management assistance
Sponsorship/Marketing Authorisation applicant
We can act as your local Australian and New Zealand Sponsor until your marketing company or distributor agreements are in place.
eCTD & NeeS services
Electronic dossier documentation services, generation and compilation of hard copy for submission to TGA &/or Medsafe.
Medical and Scientific Affairs Consulting
Medical Information outsourcing services
Medical Information outsourcing, QA procedures in place and Promotional Material Review in accordance with Legislation and Industry Codes of Conduct.
Pharmacovigilance outsourcing services
Pharmacovigilance gap analysis/ inspection-audit readiness reports +solutions, and pharmacovigilance outsourcing activities for Sponsors.
Quality Assurance (QA) activities, Standard Operating Procedure(SOP) development, Regulatory/Quality assurance interface activities, Medical Information/Quality assurance interface activities, Pharmacovigilance/ Quality assurance interface activities activities, Start Up company suite of SOPS, GMP technical agreements, Wholesaling/Distribution consulting services, Quality Management Systems and compliant QMS database solutions, Audit/Inspection readiness (TGA and Internal) and so much more.