INNOVADERM CRO IS NOW INDERO.

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End-to-End Regulatory & Clinical Development Services

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

  • Pre-IND (Includes CMC and Pharmacology/Toxicology)​
  • Investigational New Drug (IND)
  • Investigational Medicinal Product Dossiers (IMPD)
  • Clinical Trial Applications (CTA)
  • Expedited Suspected Unexpected Serious Adverse Reaction (SUSAR) to regulatory authorities and Central Institutional Review Board (cIRB)
  • End of phase II (EOP2)
  • New Drug Application (NDA)
  • Marketing Authorization Applications (MAA)
  • Abbreviated New Drug Applications (ANDAs)
  • Clinical Trials Information System (CTIS) submission
  • EudraVigilance Medicinal Product dictionary drug product registration for CTIS

Regulatory Device Submissions

  • Investigational Device Exemption (IDE)
  • 510(k)
  • Premarket Approval (PMA)

Medical & Scientific Writing

  • Clinical protocols
  • Synopsis development
  • Report on Previous Investigations (ROPI)
  • Clinical sections of regulatory submissions
  • Clinical Study Reports (CSR)
  • Serious Adverse Event (SAE) narratives
  • Investigator’s Brochures (IB)
  • Pediatric Study Plan (PSP) and Pediatric Investigation Plan (PIP)

Thibaud Portal

Founder and CEO
Alys Pharmaceuticals

Andrea Epperly

Global Head of Project Management
Alys Pharmaceuticals

Thibaud Portal

Founder and CEO
Alys Pharmaceuticals

Andrea Epperly

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 Development Plan (CDP)
  • Clinical development strategy
  • Study design recommendations
  • Endpoints and inclusion and exclusion criteria advice
  • Alignment with regulations
  • Literature review

 

Clinical Pre-Feasibility 

  • Meetings with KOLs
  • Pre-feasibility report writing
  • Support in literature review

Meeting with Regulatory Agencies

  • Support agency meeting preparation
  • Writing narratives for agency questions
  • Optimal communications with FDA, EMA, and other global agencies
  • Sponsor representation
  • Briefing documents support for every global regulatory meeting, anywhere in the world

 

Regulatory Consultation

  • EU Clinical Trial Regulation No 536/2014 consultancy
  • EU CTIS consultancy
  • Regulatory strategy consultancy
  • Preclinical toxicology consultancy
  • Preclinical pharmacology consultancy
  • CMC consultancy

Where Regulatory Rigor Meets Scientific Insight​

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.

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.

Jeff Smith

Chef de la direction

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.

Revolutionize Your Topical Trials

Efficacy insights in days, not months.

 Indero’s Early Phase 1 model enables sponsors to initiate topical studies that detect early pharmacodynamic signals much sooner than traditional phase 1, using microdosing and transcriptomic analysis. This approach reduces preclinical requirements, shortens study duration from 8–12 weeks to ≤3 days, and lowers costs, helping teams make informed go/no-go decisions faster.