Regulatory

FDA Regulatory Services — simplifying the FDA process

We guide sponsors through FDA Pre-IND & IND applications with specialised expertise and in-house services, producing high-quality clinical data for FDA and EMA submission — while capturing Australia's R&D Tax Incentive.

Australian R&D Tax Incentive

Eligible biotech companies can access the Australian Government R&D Tax Incentive — a refund of up to 43.5% on qualifying R&D expenditure — providing significant cost savings to drive research forward.

505(b)(2) pathway expertise

Our strategic planning is informed by comprehensive understanding of the 505(b)(2) regulatory pathway, which permits reliance on studies not conducted by the sponsor.

In-house Pre-IND & IND support

We offer a full suite of in-house services, including medical writing for your Pre-IND package — the briefing book and meeting request letter — with subject-matter-expert guidance throughout.

High-quality clinical data for FDA and EMA submission

Australia adheres to a well-developed ethical and regulatory framework. Standard codes of conduct are adopted from the International Council for Harmonisation (ICH) and the International Organization for Standardization (ISO), and Good Clinical Practice (GCP) is mandated across all trials, ensuring high-quality results.

The Therapeutic Goods Administration (TGA) closely aligns its regulatory standards with international counterparts, including the relevant European Union guidelines, allowing for easier integration and acceptance by institutions globally. Data from studies conducted in Australia can support almost all major international regulatory applications, including the US FDA, EMA, and MHRA.

Our Quality Assurance team is fluent in FDA guidance, and we are uniquely structured as an Australian-based CRO operating primarily to capture data intended for FDA submission. All our clinical writing — including protocols, IBs, CSRs, and pharmacovigilance reports — is written in US English and structured for submission to the FDA.

Frequently asked questions

FDA regulatory services — FAQs

Is clinical trial data from Australia acceptable to the FDA?

Yes. iNGENū structures every study to satisfy 21 CFR 312.120, and all clinical documentation is written in US English and formatted for FDA submission. Data from Australian trials supports FDA IND and NDA submissions, as well as EMA and MHRA applications.

What is the 505(b)(2) pathway and how does iNGENū use it?

The 505(b)(2) pathway lets a sponsor rely on studies not conducted by them (e.g. published literature or prior findings), reducing the studies needed for approval. iNGENū plans regulatory strategy around 505(b)(2) where appropriate to save time and cost.

Do you handle Pre-IND and IND submissions in-house?

Yes. We provide full in-house regulatory support, including medical writing for the Pre-IND briefing book and meeting request, and IND assembly and submission via our FDA e-gateway — no third-party intermediaries.

How does the Australian R&D Tax Incentive reduce FDA-track trial costs?

Eligible companies can claim a refundable tax offset of up to 43.5% on qualifying R&D expenditure conducted in Australia, materially lowering the effective cost of generating FDA-ready data.

Ready to discuss your clinical trial?

Talk to our team about how iNGENū CRO can accelerate your research.

Request a proposal