Investigational New Drug (IND) Applications
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
The ACRM can help with 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, orphan diseases, and other conditions.
– Toxicology & Pharmacology Preparation
We will work 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
Our expert partners are experienced in preparing biologic product CMCs from the pre-product development stage, including but not limited to:
Product Quantitative Composition
Manufacturing Verification Supplies & Materials
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)
DSMB Charter Preparation
Investigator Brochure (IB) Preparation