regulatory support

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Accelerating Drug Development with Expert  Regulatory Strategies

Innovative Approaches for a Faster Path to Success

At TD2 Oncology, we provide tailored regulatory strategies that accelerate your drug development journey. With a comprehensive understanding of the complexities of the global regulatory landscape, we partner with sponsors to design compliance-driven approaches that optimize timelines. Our decades of expertise allow us to address unique challenges, identify opportunities, and deliver measurable results, ensuring your program stays on track.

Tailored Regulatory Solutions

Filings Made Simple

Comprehensive Support for Global Submissions

As a trusted partner for both FDA and EMA interactions, TD2 Oncology’s Regulatory Affairs Team manages every step of the regulatory submission process with precision. From Investigational New Drug (IND) filings to Investigational Medicinal Product Dossiers (IMPDs) and Clinical Trial Applications (CTAs), our experienced team ensures compliance and efficiency at every stage.

We offer:

  • IND writing, compilation, and electronic Common Technical Document (eCTD) submissions.
  • Expert preparation of IMPDs and CTAs for European regulatory approval.
  • Support for global submissions, including agencies like Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), South Korea’s Ministry of Food and Drug Safety (MFDS), and Australia’s Therapeutic Goods Administration (TGA).

Our team also specializes in clinical and nonclinical summary technical writing, investigator brochures, and informed consent forms. With TD2 Oncology, you gain a global partner who navigates the complexities of regulatory pathways, aligning strategy and execution for a seamless path to approval.

Cut Costs, Not Corners with
Our Clinical Trial Enabling Program

Accelerating Clinical Start-Up for Faster Patient Enrollment

TD2 Oncology’s Clinical Trial Enabling Program is designed to align regulatory filings with early clinical trial start-up, ensuring trials are set up for success from day one. By seamlessly integrating IND submission with clinical start-up activities, we help sites begin enrolling patients 4+ months sooner while maintaining compliance and operational efficiency, reducing delays, and ensuring trial readiness.

Key Program Benefits:

  • Clinical Strategy and Protocol Writing
  • Regulatory Document Preparation
  • Site-selection and Start-up
  • Laboratory and Logistics Vendor Identification

With TD2 Oncology’s expert guidance, sponsors benefit from a synchronized regulatory and clinical start-up strategy that accelerates timelines and ensures a smooth path to trial initiation.

Accelerating-Clinical-Start-Up

 

The TD2 Oncology Ecosystem

Seamless Integration from Preclinical to Clinical Success

TD2 Oncology offers a comprehensive suite of study management services, ensuring a seamless and efficient clinical trial process from preclinical stages through regulatory approvals and beyond. Our integrated approach includes:

  • Preclinical Services: Leveraging innovative technology and experienced scientists to deliver robust preclinical data which guide your clinical strategy.
  • Regulatory Support: Guiding you through the complex regulatory landscape with expert advice and documentation support for an expedited path into the clinic.
  • Clinical Trial Management: Providing end-to-end management of your clinical trials, from site selection and patient recruitment to data management and analysis ensuring a streamlined clinical experience.

By partnering with TD2 Oncology, you benefit from a streamlined process that minimizes delays and optimizes resource allocation, ensuring that your trial progresses smoothly at every stage. Our commitment to quality and efficiency means you can focus on your research, while we handle the operational complexities.

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Partner with TD2 Oncology for a Seamless Regulatory Journey

From IND submissions to clinical trial start-up, we ensure your program moves forward efficiently. Take the first step today and contact our experts.

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