Investigational New Drug Applications (INDs)
At AssureImmune, we understand IND submissions can be confusing and intimidating. We are here to help you every step of the way, providing you the tools and resources needed to file your IND with the FDA.
IND filing services include:
– Clinical Protocol Preparation
AssureImmune offers more than 20 indications, including but not limited to server Covid-19, Long Hauler Covid-19, COPD, diabetes, heart failure, osteoarthritis (OA), backpain, Alzheimer’s disease, atopic dermatitis, cancer, and orphan diseases.
– Toxicology & Pharmacology Preparation
AssureImmune works with you to compile the clinical and preclinical data necessary to prepare toxicology and pharmacology reports for your investigative product (IP).
– Customized Biologic Product Preparation
AssureImmune are experts in preparing biologic product CMC from the pre-product development stage, including but not limited to:
- Product Development
- Product Description
- Product Characterization
- Product Quantitative Composition
- Reagent Specification
- Manufacturing Verification Supplies & Materials
- Donor Qualification
- cGMP Facility Development & Establishment
- Manufacturing Process Development & Validation
- Final Product Specification Determination
- Filing System Development
- Product Tracking System Development
- Product Validation & Qualification
- Product Transportation Validation
- Product Sterility Testing
- Contamination Notification & Action Plan
- Product Stability Development
- Product Shelf-Life Testing (MSC, amniotic fluid, cord blood plasmid and cells, exosomes, secretome, iPSC and gene)
- ICF Preparation
- DSMB Charter Preparation
- Investigator Brochure (IB) Preparation
- FDA Submission
- FDA Communications