Office in Melbourne

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms. We are a physician-led, full-service CRO with deep subject matter expertise across a vast number of therapeutic areas. 

We have an established network of in-house clinical trial research professionals including medical writing, quality assurance, scientific affairs, biostatistics, data management, pharmacokinetics, project management, monitoring, safety, and pharmacovigilance. 

OUR FDA-EXCLUSIVE FOCUS: 

As a full service CRO, our team members have significant FDA experience and hundreds of clinical trials behind them. Our unique, FDA-exclusive focus has created a CRO performing: 

1. Clinical Trials (Phase 1, 2 and 3) 

2. IND-Enabling Non-Clinical Studies with Data in FDA-Compliant SEND Format 

3. FDA Regulatory Submissions (PIND, IND, NDA)

WHY WORK WITH US: 

1. Diverse Therapeutic Specialty Leaders: Our team comprises physician and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions that meet your unique clinical trial needs. 

2. FDA Regulatory Expertise: With extensive experience in FDA regulatory work, we specialize in making full FDA pre-IND and IND submissions for our clients. 

3. Fast, High-Quality Research: We excel in conducting fast-paced research that strictly adheres to FDA guidelines and regulations. Our clients' timelines are met without sacrificing quality.

E-mail: hello@ingenucro.com

Web: https://www.ingenucro.com/

Phone: +1300 633 226