Our Service Areas

Regulatory and submission strategy

Submission pathways evaluation (eg. priority review, provisional application) 

Joint submission evaluation (eg. project ORBIS, ACSS, Asean Joint Assessment)

Dossier review, gap analysis, editing and publishing

Designation preparation (eg. orphan drug)

Labelling review against regulatory standards

Submission modules preparation and review

Dossier submission and follow-up

Receive and review agency questions

Develop effective and concise responses

Evaluation reports review

Finalise artwork and labelling

Review proposed manufacturing changes

Assess regulatory impact and manage submission

Review new safety information

Labelling updates 

PSURs submissions

Product licence and GMP renewals

IND (CTN/CTA) review, preparation and submission

HREC and local IRB submission

Study start-up activities for early phase studies (through a partner)

GMP review and applications

CPP and GMP certificate applications

Attending meetings with health agencies (eg. pre-submission, key negotiation)

Regulatory staff training and coaching

Authorised representative for overseas pharma companies

Review of draft regulatory guidance

Regulatory project management