Regulatory Support

Regulatory success. By design.

TD2’s Regulatory Affairs Team engages Oncology drug development experts and strategists with proven track records of success. We leverage experienced, oncology-focused medical writers, regulatory experts in CMC, pharmacology, and toxicology, as well as regulatory program managers to provide a customized approach across all areas of drug development.

Strategic Consulting

Translational Regulatory Services

Partner with a trusted, experienced team to guide your preclinical and IND-enabling studies.

Program Management

Program Management

A customized approach to regulatory strategy.

There is no one-size-fits-all approach to regulatory strategy, but with diligent planning and scientific research, we are able to identify unique regulatory opportunities as well as risks that could delay your development program. Chemistry, Manufacturing and Controls (CMC) is a critical path activity that requires careful planning and execution, and we have an expert team to help navigate those challenges. In addition, our Pharmacology and Toxicology experts have decades of experience with small molecules, large molecules and biologics. Close communication keeps your timelines on track moving your therapy forward, faster.

Chemistry, Manufacturing and Controls

Chemistry, Manufacturing and Controls

Expert CMC guidance

When it comes to CMC, TD2 provides unparalleled support. Here’s where we offer dedicated counsel and strategy:

  • Vendor selection
  • Preformulation and formulation
  • RFP management
  • Technology transfer to manufacturing (GMP)
  • QA audits
  • Physical and chemical characterization
  • Product line extension
  • Technical regulatory submission writing

Pharmacology, Toxicology and Pharmacokinetic Testing

Comprehensive nonclinical safety support.

Our pharmacology and toxicology experts guide you through the design and implementation of oncology drug development plans, as well as preclinical programs for small molecules, proteins, peptides, antibodies, drug-delivery systems, cell-based therapies and more. Throughout the regulatory process, we interact with the necessary partners and agencies to coordinate multi-disciplinary product development, so no box goes unchecked.

Here’s what else we offer:

  • Management of studies at contract facilities
  • Analytical method development
  • Establishment of QA/QC documentation systems
  • Non-GLP and GLP study design
  • Nonclinical and analytical study monitoring
  • Regulatory filings and technical writing
  • QA audits
Pharmacology, Toxicology and Pharmacokinetic Testing
Regulatory Fillings

Regulatory Fillings

A trusted partner throughout the regulatory process.

Acting as a primary contact to the FDA on behalf of you as a Sponsor (and U.S. agent if you are a non-U.S. Sponsor), our regulatory team represents you through the entire Investigational New Drug (IND) process and all FDA interactions. Our turn-key services make the IND process seamless and timeline-driven. Once your IND is submitted to the FDA, we communicate regarding IND protocol amendments, safety reports and annual reports

  • IND writing, compilation and electronic Common Technical Document (eCTD) submission
  • Clinical and nonclinical summary technical writing
  • Medical writing services including investigator’s brochure (IB), clinical protocol design and writing and Informed
  • Informed Consent Form (ICF) development
  • IND assembly and publishing (word processing, intra- and inter-document hyperlinking, etc.)

TD2 can also assist with specialty filings throughout the drug development process, including but not limited to:

  • Orphan Drug Designation
  • FDA’s Expedited Programs such as:
    • Breakthrough Therapy Designation
    • Fast Track Designation
    • Subpart H: Accelerated Approval
    • Priority Review Designation
  • Compassionate or Emergency Use
  • Other programs such as Real-Time Oncology Review (RTOR), Assessment Aid Pilot Project and Pediatric Study Plans

GET STARTED

Have questions about how TD2 can assist with your regulatory needs?

Reach out to our expert staff today to get started.

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