Translational Regulatory Services
Partner with a trusted, experienced team to guide your preclinical and IND-enabling studies.
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
Expert CMC guidance
When it comes to CMC, TD2 provides unparalleled support. Here’s where we offer dedicated counsel and strategy:
- Vendor selection
- RFP management
- QA audits
- Product line extension
- Preformulation and formulation
- Technology transfer to manufacturing (GMP)
- Physical and chemical characterization
- 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
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 Services
- 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.)
Specialty Filings
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
Additional Resources
Regulatory
Oncology Drug Approval Process
Regulatory
What are the Types of INDs?
Preclinical, Webinars
