Expert regulatory consulting for the pharmaceutical and biotech industry — ensuring compliance, accelerating approvals, and minimising risk
About Us
Lumen Life Sciences was founded by Sarah Henderson, following several years working as Head of Regulatory for a leading Australian regulatory and clinical consultancy.
Prior to this, she spent time working in regulatory affairs for large pharmaceutical companies both in Australia and the UK.
She is an active member of the industry, participating as a member of Ausbiotech's RegTech industry group for medical devices and has chaired sessions at the ARCS conference.
Sarah has a flexible, client focused approach and is passionate about ensuring the best outcome from both a regulatory and commercial perspective.
Sarah runs LLS from Australia’s national capital, Canberra.
Our Services
Lumen Life Sciences provides consulting services across early phase development, clinical trials, marketing authorisation preparation/submission and lifecycle management.
Early Phase Development and Clinical Trial support
Regulatory strategy and pathway planning
Review of early clinical or non-clinical data
Investigator's Brochure (IB)
IND submissions (US)
CTN and CTA submissions (Australia)
Human Research Ethics Committee (HREC) submissions
Prescription medicines, OTCs and Complementary medicines
Dossier review/gap analysis and dossier compilation
Assessment of regulatory pathway options (priority review, provisional approval, orphan drug designations, COR, Access Consortium, Project Orbis, literature-based submissions)
Presubmission meetings
Submission and management of new medicine applications (marketing authorisation)
Lifecycle management (variations to a medicine registration)
Medical Devices
Technical file review
Manufacturer's evidence review and submission
Device Inclusion submissions
Regulatory Publishing
We offer regulatory publishing in eCTD or NeeS format for a range of submission types including INDs, initial submission (MAAs, NCEs) or lifecycle management.
Other products and services
Sunscreens
Cosmetics
Food Products
Disinfectants
Authorised prescriber and Special Access Scheme support