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Regulatory & Clinical Development Consulting

End-to-end regulatory, drug, and clinical development consulting that supports more efficient outcomes.

Regulatory & Clinical Development Team Members

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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 2 (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.

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Successfully Supported Pre-IND Submission & FDA Meeting for Vitiligo Asset

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.

Services

Pre-IND Submission Development

  • Clinical Section Development: Assisted in preparing the required pre-IND submission package, detailing their planned clinical activities.
  • Study Synopsis: Developed the study synopsis and plan for their first clinical study, ensuring alignment with regulatory requirements.

FDA Question Development

  • Question Formulation: Created a set of questions for the FDA, including rationale and study design suggestions, based on our extensive experience.
  • Literature Analysis: Conducted literature reviews to support the proposed study designs and questions.

Meeting Preparation

  • Scenario Planning: Prepared narratives for various potential FDA scenarios, helping the client anticipate and prepare for different outcomes.
  • FDA Meeting Representative: Actively participated in the FDA video conference to provide real-time answers to any questions. Developed a supportive document to address the FDA’s clinical questions, incorporating literature research and client discussions.

Outcome

FDA Meeting

  • The client successfully engaged with the FDA in a virtual meeting.
  • Despite high concerns, the FDA agreed with their proposed plan by the end of the meeting.

Regulatory & Clinical Development Consulting That Accelerates Studies

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.

ABOUT INDERO

“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!”

Carine Blanchard

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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Jeff Smith

Chef de la direction
Linkedin

Jeff Smith, Chef de la direction d’Indero Recherches, apporte prĂšs de 30 ans d’expĂ©rience dans l’industrie pharmaceutique et CRO, s’Ă©tant distinguĂ© par son leadership exceptionnel, sa vision stratĂ©gique et son innovation. L’expertise de Jeff couvre des opĂ©rations mondiales, la gestion de la croissance, ainsi que la promotion d’une culture d’entreprise collaborative. Ses atouts en matiĂšre de crĂ©ation de valeur, de gestion des partenaires et d’opĂ©rations CRO ont toujours contribuĂ© au succĂšs dans ses fonctions prĂ©cĂ©dentes. Sous la direction de Jeff, Indero continue d’étendre ses capacitĂ©s, faisant progresser les connaissances mĂ©dicales et les nouvelles thĂ©rapies 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.
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