Our Services

Regulatory Affairs Consulting

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

Prescription medicines

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.

Biotech medicines

New entities, Biosimilars, line extensions, major variations & general maintenance.

Generic medicines

New generics, bioequivalence study management & general maintenance.

OTC medicines

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

Coordinate liaison with the TGA &/or Medsafe, coordinate briefing packages and attendance at meeting, general regulatory enquiries and liaison activities.

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

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.

Training

In house regulatory affairs training, in house pharmacovigilance training, in house GMP basics training