FDA Regulatory Services

As a full-service CRO, our team members have the experience of hundreds of clinical trials behind them.

Our team is fluent in the FDA guidance documentation, the IND processes, and the unique requirements of the 505(b)2, the 505(b)1 and ANDA pathways. 

FDA Regulatory Services

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US FDA Pre-IND & IND Application
iNGENū CRO extends its expertise in guiding you through the critical stages of FDA Pre-Investigational New Drug (Pre-IND) and Investigational New Drug (IND) applications. Our team comprises professionals from diverse backgrounds, including clinical, nonclinical, regulatory affairs, and Chemistry, Manufacturing, and Control (CMC).
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Research & Development Tax Incentive (RDTI)

Working with an Australian-based CRO has its advantages. One significant benefit is the potential eligibility for Australia's Research & Development Tax Incentive (RDTI). This incentive allows a 43.5% refund on qualifying R&D expenditure, plus providing significant cost savings to drive your research forward.

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Specialized Regulatory Expertise

Our strategic planning and consulting are informed by our team's comprehensive understanding of the 505(b)(2) regulatory pathway, which permits reliance on studies not conducted by the sponsor.

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Complete In-house Service Offering

Consolidation is key to efficient and effective communication, which is why iNGENū CRO offers a full suite of in-house services. This includes the critical task of medical writing for your Pre-IND package, including the briefing book and the meeting request letter, whilst receiving the subject-matter expert guidance.


Commitment to High Quality Clinical Data for FDA and EMA submission

Australia adheres to a well-developed ethical and regulatory framework. The standard codes of conduct are adopted from the International Conference on Harmonisation (ICH), and International Organization for Standardization (ISO).

Australia’s scientific and clinical community also mandates the standards of good clinical practice (GCP) across all trials, ensuring high-quality results. The Therapeutic Goods Administration (TGA) also closely aligns its prevailing regulatory standards with international counterparts including the relevant European Union guidelines, allowing for easier integration and acceptance by institutions globally. 

Data output quality from studies conducted in Australia can be used to support almost all major international regulatory applications, including the US FDA and European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA).

At iNGENū, our Quality Assurance team are fluent in FDA guidance and we are uniquely structured as an Australian-based CRO operating primarily to capture data intended for FDA submission. Hence, all our clinical writing (including Protocols, IB’s CSRs, Pharmacovigilance reports) is written in US English and structured for submission to the FDA.

Ready to discuss your trial?