Therapeutic Expertise
Novel Formulations
We specialise in the clinical development of novel and reformulated products — the modified-release, long-acting and combination formulations that other CROs find challenging. Our team pairs formulation science with a clear 505(b)(2) regulatory path.
Novel formulations demand PK-led study designs — bioavailability, bioequivalence, food-effect and dose-proportionality work — and a regulatory strategy that maximises the value of existing safety data. We design efficient programmes that leverage the 505(b)(2) pathway to reach the clinic faster and at lower cost.
Addressing common pain points in novel formulations clinical trials
Demonstrating comparability and bioequivalence
Reformulated products must show a well-characterised PK relationship to the reference product.
We design and run BA/BE, food-effect and dose-proportionality studies with FDA-audited units and validated bioanalysis.
Choosing the optimal regulatory pathway
The wrong pathway adds cost and delay for a reformulated product.
We build a 505(b)(2) strategy that leverages existing literature and reference data to minimise new studies.
Bridging safety from the reference product
Sponsors must justify how existing safety data applies to the new formulation.
We assemble bibliographic and bridging evidence to minimise the number of new non-clinical and clinical studies required.
The iNGENū CRO difference
Australian expertise, direct FDA submission
We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Trial data from Australia can be submitted directly to the FDA via our E-Gateway, eliminating the need for third-party intermediaries.
iNGENū takes a highly strategic and disciplined approach to clinical research, ensuring every dollar is directed toward generating meaningful outcomes — eliminating unnecessary costs while maintaining the highest scientific and regulatory standards across the Asia-Pacific region.
“We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug — medical writing, project management, clinical data management and full end-to-end execution and monitoring. We have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads during this clinical trial.”
Giles MossChief Executive Officer
Ready to discuss your Novel Formulations clinical trial?
Talk to our team about how iNGENū CRO can accelerate your research.
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