A customized approach to regulatory strategy.
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
A trusted partner throughout the regulatory process.
- 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
- 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