Partner with Indero’s Regulatory & Cilnical Development Team
Indero provides unparalleled regulatory, drug and clinical development consulting services to support your success. Tell us about your clinical trial needs.
End-to-end regulatory, drug and clinical development consulting that supports more efficient outcomes.
Looking to break into another country’s market? Need support with your regulatory submissions or regulatory guidance? Accelerate your drug development project and reclaim valuable time by working with Indero.
Regulatory Drug Submissions
Regulatory Device Submissions
Medical & Scientific Writing
Founder and CEO
Alys Pharmaceuticals
Global Head of Project Management
Alys Pharmaceuticals
Founder and CEO
Alys Pharmaceuticals
Global Head of Project Management
Alys Pharmaceuticals
“Congratulations to the team for a very positive pre-IND meeting outcome! Your dedication, and well-executed plans have laid a strong foundation for our program. This success is a significant trust-building milestone with the agency. Thank you for your outstanding work!”
Scientific Support
Clinical Pre-Feasability
Meeting with Regulatory Agencies
Regulatory Consultation
Study Design
From adaptive design, MOA, SAD-MAD-POC, MUsT, MUSE, Intraindividual, disease characterization, we have mastered the art of scientific innovation while strictly complying with regulatory requirements.
Endpoint Selection
Aligning with FDA expectations, championing patient-centric values, and crafting feasible study designs with uncompromised data quality.
Biomarker Use
We elevate translational research strategies, daring to venture beyond traditional sampling techniques. Our dedicated exploration of biomarkers is conducted with the utmost level of sensitivity.
Indero provides unparalleled regulatory, drug and clinical development consulting services to support your success. Tell us about your clinical trial needs.
The client sought support for their pre-IND submission and development program. Our goal was to contribute to the clinical section of the pre-IND submission package and prepare clinical questions for their Vitiligo asset.
Pre-IND Submission Development
FDA Question Development
Meeting Preparation
FDA Meeting
Scientific discipline. Operational efficiency. Clinical development expertise. Our end-to-end regulatory and clinical development consulting services provide the rigorous foundation, quality data and expertise dermatology & rheumatology studies need to ensure effective execution and on-time delivery.
“Great experience working with the Indero team for our pre-IND and IND preparation. Knowledgeable, collaborative, and truly patient-oriented. Working together as a single team—highly recommend!”
Chief Scientific Officer
Aldena Therapeutics
Wherever You’re Going,
We’re all in.
Need help with your next study? We want to learn more. Fill out the form on the right and one of our experts will be in touch.
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Our long-standing relationships with key opinion leaders and highly performing sites, result in optimized start-up processes that deliver strong results in the least amount of time. As part of our site evaluation, our team utilizes past performance metrics, recruitment projections based on competitive landscape, and detailed feasibility surveys to determine a site’s capabilities and interest in a study.
Our dedicated patient recruitment and advertising team integrates with the study team to tailor recruitment strategies, customize central ad campaigns, develop advertising creative, and continuously track and adapt recruitment goals. Our patient-centric approach is enhanced by Clinago, our technology enabled recruitment service.
We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.
We orchestrate all study activities and deliverables, including site selection process, budget and contract negotiations, and patient engagement, recruitment enrollment projections, all while respecting your study timelines.
