Pre-IND, IND, & NDA Services
Pre-IND, IND, and NDA services
The FDA pre-IND and IND process forms the backbone of your go-to-clinic strategy during drug development. Done correctly, this process can add tremendous value to your program and your company. To achieve successful results while saving time and money, you need a team that can build a successful team focused on your product. The team is responsible for:
- Clinical study design and clinical protocol writing
- Toxicology literature review and nonclinical study design
- Formulation development and CMC
- Clinical material manufacturing, packaging, and supply chain
- FDA regulatory writing and strategy
- Clinical site review and management
THE VICI ADVANTAGE
We're not just regulatory writers - as scientists and regulatory professionals, we understand all aspects of drug development and can deliver an efficient pre-IND meeting and successful IND to rapidly bring your concept to clinic.
Pre-IND meeting services
- Pre-IND meeting request
- Pre-IND meeting strategy
- Writing the briefing book
- FDA meeting project management and participation
- Verification of pediatric study plan or pediatric waiver request
IND writing and submission
- Full IND writing
- IND publishing in the Electronic Common Technical Document (eCTD) format, which is the standard format for submissions to the FDA
- Module 1 – label review, investigator brochure
- Clinical trial design and review for completeness
- Non-clinical study design, review, and overview of execution – for route of administration change for 505(b)(2) filings
- Submission of foreign dossier or clinical trials for US FDA submission
- Fast track designation/ orphan designation / breakthrough therapy / accelerated approval
- iPSP initial pediatric study plan or waiver request
- IID comparison table
Talk to us today about our rates for pre-IND meeting services, project management, and IND writing and submission services.