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Accelerating Clinical Success with IND Expertise
- Clinical Research and IND Enablement
- IND Enablement for Diverse Therapeutic Areas
We work closely with sponsors to design comprehensive regulatory strategies tailored to their therapeutic candidate. By integrating scientific insight with regulatory expertise, we lay the foundation for successful IND submissions.
- Early-phase guidance for clinical protocol development.
- Pre-IND meeting preparation and regulatory authority engagement.
- Gap analysis of data requirements to meet FDA or global standards.
- Compiling regulatory dossiers, including preclinical, clinical, and CMC (chemistry, manufacturing, and controls) data.
- Authoring and reviewing core modules of the eCTD (electronic Common Technical Document).
- Addressing FDA feedback with prompt, clear, and compliant responses.
Our team ensures that every aspect of your IND application is meticulously prepared, reviewed, and submitted.
Beyond the IND submission, we offer ongoing regulatory support to maintain compliance and advance your clinical development programs.
- Amendments and annual IND reporting.
- Guidance on safety reporting, including adverse events and serious adverse event (SAE) management.
- Ensuring compliance with FDA, EMA, and global clinical trial requirements.
At Clinartis, we understand that every program is unique. Our experience spans multiple therapeutic areas and product types, including:
- Small molecules and biologics
- Cell and gene therapies
- Vaccines
- Orphan and rare disease therapies
- Biosimilars
Strategic Engagement with Regulatory Authorities
Successful regulatory interactions are critical to ensuring the approval and advancement of therapeutic programs. At Clinartis, we excel in facilitating constructive and efficient communication with regulatory authorities such as the FDA, EMA, MHRA, and other global agencies. These interactions form the backbone of a proactive regulatory strategy, reducing uncertainty and accelerating program timelines.
Pre-Submission Engagement
Our team prepares and supports sponsors in key early-stage regulatory meetings, including Pre-IND, End-of-Phase 1, and Type B and C meetings. By anticipating agency expectations and addressing potential concerns, we help sponsors gain critical insights and align their development plans with regulatory expectations.
Comprehensive Meeting Support
From authoring meeting briefing packages to scripting sponsor presentations and addressing post-meeting queries, our team ensures seamless interactions with regulatory bodies.
Agency Liaison Services
Acting as an intermediary, we foster clear and timely communication with regulators, addressing questions, clarifying requirements, and advocating for our sponsors' programs to move efficiently through the review process.
Global Regulatory Strategy
Our team has experience navigating regulatory systems beyond the FDA, including centralized and decentralized procedures for the EMA, as well as requirements for Asian and Latin American markets. This global approach ensures that sponsors can scale their programs internationally with confidence.
Expertise in Addressing Agency Feedback
Navigating regulatory feedback is an essential part of ensuring compliance and advancing development timelines. At Clinartis, we specialize in interpreting regulatory comments and crafting comprehensive responses that address concerns while strengthening the overall program:
Resolution of Complex Issues
Whether addressing deficiencies in CMC sections, clarifying clinical trial protocols, or resolving safety concerns, we provide scientifically robust and strategically sound solutions.
Negotiating Pathways for Accelerated Approval
For programs in breakthrough or rare disease areas, we work closely with regulatory agencies to explore expedited pathways, such as Fast Track, Breakthrough Therapy Designation, or Orphan Drug Designation.
Handling Advisory Committee Interactions
For sponsors preparing for FDA advisory committee meetings, our team offers strategic guidance, helping shape sponsor narratives, responses, and scientific presentations.
Through effective communication and trusted relationships with regulators, Clinartis ensures that your therapeutic programs meet compliance standards and maintain forward momentum, bringing you closer to clinical success.
Why Clinartis for IND Enablement?
Supporting Your Journey from Bench to Bedside
At Clinartis, our mission is to simplify the regulatory process, enabling you to focus on what matters most: developing life-changing therapies. Whether you’re filing your first IND or scaling clinical trials globally, our team is your trusted partner in achieving regulatory success.