IND-enabling Studies
The IND Enabling Process
To study a product in human clinical trials, an investigational new drug (IND) application to the Food and Drug Administration (FDA) will be submitted. Data and information included in the submission will include regulatory pathway and intended labeling information, non-clinical (animal) studies, chemistry, manufacturing and controls data, and proposed clinical study protocols. Vici Health Sciences is able to project manage the entire IND process to successful submission.
To facilitate a successful submission, Vici offers the following services:
Regulatory services
- Gap analysis of current progress and strategic regulatory advice
- Identifying eligibility for priority review by the FDA by designation of fast track, breakthrough therapy or accelerated approval strategies
- Authoring and eCTD publishing of the IND
- Submission of annual reportable
Drug Substance Manufacturing
- Vici Health Sciences is skilled at GMP manufacturing active pharmaceutical
- Knowledge on GMP requirements for synthesis of drugs to ensure FDA compliance
Pre-formulation
- Solubility and physical characterization
- API stability
- Polymorph screening
Formulation Development
- Expertise in development of topical, oral, or buccal dosage forms
- Specialization in intellectual property generation
GMP manufacturing of finished dose product
- After completion of formulation development, clinical trial material must be manufactured
- GMP suites
Analytical Development and Release Testing
- Knowledgeable on phase appropriate development
- Phase appropriate method validation
Stability studies
- Calibrated stability chambers appropriate for accelerated storage, intermediate storage and controlled room temperature storage
- Stability studies will support shelf life of the product during the clinical trial