Submitting an Investigational New Drug (IND) application requires strategic regulatory planning, FDA compliance, and efficient execution. A well-prepared IND package accelerates regulatory approvals, ensures a smooth transition to clinical trial activation, and minimizes delays. We provide expert regulatory support, preclinical study management, and clinical trial enablement to optimize the IND submission process for biotech and pharmaceutical companies.
Download Our Free IND Readiness Checklist
For a step-by-step guide to IND preparation and submission, download our IND Submission Checklist by completing the form to ensure you have all critical components in place for a successful FDA IND application.
Download the IND Readiness Checklist
Your Partner in IND & Clinical Trial Success
We provide an integrated approach to IND submission and clinical trial activation, ensuring that every component of the process aligns for a faster, smoother transition from regulatory approval to trial initiation. Our expert team streamlines regulatory planning, preclinical development, and site activation, minimizing delays and reducing trial startup time.
- Preclinical Development & Data Preparation: Our preclinical services ensure all necessary toxicology, pharmacokinetics (PK), pharmacodynamics (PD), and CMC studies are conducted according to FDA IND submission guidelines.
- Regulatory Strategy & IND Submission: Regulatory experts provide end-to-end support, from KOL Expert Panel discussions to eCTD IND submissions, ensuring accuracy, compliance, and strategic dossier development.
- Clinical Trial Planning & Site Engagement: We helps sponsors prepare for Phase 1 clinical trials, ensuring sites are qualified, trained, and ready to enroll patients as soon as IND approval is received.
- Risk Mitigation & Strategic Planning: Our risk management solutions help sponsors anticipate regulatory challenges, conduct gap analyses, and develop strategic plans to avoid delays.
TD2 Oncology Exclusive: Seamless Strategy for Accelerated Trial Readiness
To accelerate trial activation, our unique Clinical Trial Enabling Program ensures that essential clinical start-up activities occur concurrently with the IND submission process, allowing sites to activate immediately upon IND approval. Key activities include:
- Regulatory Document Preparation: Ensuring all required documentation is compiled and submitted efficiently.
- Clinical Strategy & Protocol Finalization: Aligning early-phase trial design with regulatory expectations to prevent delays.
- Site Selection & Start-Up Coordination: Identifying and activating high-performing trial sites in advance.
- Laboratory & Logistics Vendor Identification: Establishing key partnerships for efficient trial execution.
- Operational Readiness Planning: Ensuring that all site and sponsor operations are in place for immediate activation post-IND approval.
Our unique Oncology Ecosystem has all the pieces in place to make your IND submission and clinical trial launch seamless. Let us help you accelerate your drug development timeline and reduce regulatory roadblocks.
