Partner with Indero’s Regulatory & Clinical Development Team
Indero provides unparalleled regulatory, drug, and clinical development consulting services to support your success. Tell us about your clinical trial needs.
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-Feasibility
Meeting with Regulatory Agencies
Regulatory Consultation
Study Design
From adaptive design, MOA, SAD-MAD-POC, MUsT, MUSE, intraindividual, and 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 and 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
Rheumatology CROs navigate regulatory challenges by staying updated on the latest guidelines and leveraging their expertise in the field.
Key strategies include:
Understanding complex guidelines: Ensuring compliance with global regulatory standards for rheumatology treatments
Navigating multiple markets: Managing submissions and approvals across various jurisdictions
Adapting to therapeutic nuances: Tailoring strategies to the unique characteristics of dermatology and rheumatology drugs, such as biologics and disease-modifying anti-rheumatic drugs (DMARDs)
Proactive communication: Collaborating with regulatory agencies to anticipate and resolve challenges before they arise
Regulatory consulting plays a crucial role in fast-tracking drug development by providing expert guidance on every stage of the regulatory process. Consultants, like the experts at Indero, help define the most efficient pathways for approval, identify and navigate expedited programs like the FDA’s Fast Track and EMA’s accelerated assessment, and ensure compliance with complex regulatory requirements. By anticipating potential regulatory hurdles early in the process, they enable sponsors to make quicker, more informed decisions, minimizing delays and accelerating time to market.
Preparing for an IND submission typically involves the following steps:
Preclinical data collection: Gather comprehensive data on safety, pharmacology, and toxicology.
CMC (chemistry, manufacturing, and controls): Prepare a detailed CMC section outlining manufacturing processes.
Clinical trial design: Develop a plan for clinical trials, including phase 1 study protocols.
Regulatory strategy: Establish clear regulatory pathways and ensure alignment with FDA or EMA guidelines.
Submission: Compile and submit all documentation for review by regulatory authorities.
An experienced CRO partner, such as Indero, can help you navigate this process.
Regulatory challenges in rheumatology often involve unique considerations, including:
Complex biologics: Many rheumatology treatments are biologics, requiring specialized regulatory approaches for approval
Long-term efficacy: Demonstrating long-term benefits of treatments for chronic diseases
Evolving guidelines: Regulatory requirements in rheumatology are rapidly evolving, particularly around personalized medicine and biosimilars
Rare disease considerations: Developing treatments for rare rheumatologic conditions may involve more complex regulatory pathways due to limited patient populations
Indero employs a customized, strategic approach to regulatory submissions, ensuring that each step aligns with both the regulatory environment and client goals. The process includes early consultation to identify potential challenges, as well as proactive engagement with regulatory bodies to smooth out any obstacles. We leverage global expertise in regulatory affairs to ensure compliance across multiple regions and tailor our strategies to the specific needs of the therapeutic area. This approach helps optimize submission timelines and improves the chances of successful approvals.
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.
Jeff Smith, Chef de la direction d’Indero Recherches, apporte près de 30 ans d’expérience dans l’industrie pharmaceutique et CRO, s’étant distingué par son leadership exceptionnel, sa vision stratégique et son innovation. L’expertise de Jeff couvre des opérations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matière de création de valeur, de gestion des partenaires et d’opérations CRO ont toujours contribué au succès dans ses fonctions précédentes. Sous la direction de Jeff, Indero continue d’étendre ses capacités, faisant progresser les connaissances médicales et les nouvelles thérapies en dermatologie et en rhumatologie.
