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
- NDA regulatory writing and strategy for FDA filing
- 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.
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Pharmaceutical Solutions for Product Development
From compounds to commercial production, we are the pharmaceutical product manufacturing partner you can rely on. Discover why Vici is the best CDMO for pharma production. Speak with one of our experts about your project today.