▶ WHAT WE DO: iNGENū CRO delivers FDA-compliant clinical trials for US Biotechs and saves them 70% of their clinical trial costs... without the lengthy timelines typically associated with clinical trials. We manage all the heavy lifting to ensure that our clients can focus on what they do best – creating life-saving treatments.▶ OUR FDA-EXCLUSIVE FOCUS:As a full-service CRO, our team members have the experience of 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 Format3. FDA Regulatory Submissions (PIND, IND, NDA)▶ WHY WORK WITH US:1. Government Grant Access: As an Australian CRO, all our clients (clinical and non-clinical) will receive up to 43.5% Government R&D Incentive to perform their research with us.2. 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.3. FDA Regulatory Expertise: With extensive experience in FDA regulatory work, we specialize in making full FDA pre-IND and IND submissions for our clients.4. Diverse Therapeutic Specialty Leaders: Our team comprises physicians and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions for your unique clinical trial needs.▶ OUR TYPICAL CLIENT:An early-stage US biotech company who is looking for:• > 70% reduction on their trial costs• Clinical trial startup time in 8-10 weeks• Commence FIH clinical trials prior to opening an IND• All data being 21 CFR 312.120 compliant for US FDA submission• Rodent and second-species nonclinical studies at a fraction of the cost of the US▶ TYPES OF BUSINESSES WE’VE WORKED WITH:⭐ Biotech Startups⭐ Mid-sized Pharmaceutical Companies⭐ Medical Research Institutions⭐ Medical Device⭐ Physician-led biopharmaceutical companies▶ READY TO TALK?☎️ Like to find out more? Reach out to me at adam.moodie@ingenucro.com to start collaborating. Let’s unlock the potential of your clinical assets and bring them to market successfully.#ClinicalTrials #Biotech #Pharmaceuticals #HealthTech #MedicalResearch #FDACompliance #BiotechInnovations