Amanda Devito Email & Phone Number

▶ WHAT WE DO: iNGENū CRO delivers FDA-compliant clinical trials for US Biotechs and saves them 70% of their clinical trial costs... without the need to open an IND not complete full IND-enabling sequence of studies.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 I, II, and III) 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. 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. We ensure that 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 physician and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions that meet the unique demands of your clinical trials.▶ OUR TYPICAL CLIENT: An early-stage US biotech company who is looking for: • >70% cost reduction on FDA-compliant clinical and nonclinical trials • All data being 21 CFR 312.120 compliant for US FDA submission • Clinical trial startup time in 8-10 weeks • Commence FIH clinical trials prior to opening an IND • Perform 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 Companies⭐ Physician-led biopharmaceutical companies▶ READY TO TALK? ☎️ Like to find out more? Reach out to me at sud.agarwal@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

Listed skills include Leadership, Project Planning, Time Management, Tagalog, and 45 others.