Product Development
Partner with the Experts
Lean on us for evidence-based product formulations for human and animal patient populations.
RESEARCH PARTNERS
The Compounding Advantage
Given Innovation Compounding’s platform of delivering specialty pharmaceuticals across the country, our pharmacy can support drug trial investigators, clinicians, directors, and sponsors to construct and implement clinical studies.
Our team of pharmacists, quality assurance, and other personnel can help you develop a drug trial plan that is in satisfy the needs of the drug study as well as compliance with multiple standards enforced by both federal and state agencies.
In addition, our rigorous QA standards will provide complete transparency in how we produce your products, which is often a requirement for many studies. Viewed as a partner, both public and private research entities rely on us to deliver on those standards.
Our Process for Product Development
Needs Assessment
The Process
- Establish project goals
- Determine the scope of services
- Strategy for formulating the product
- Review of regulatory requirements
- Contract proposal
Literature/Evidence Review
Expected Research Time is 12-15 Hours
- Expected Research Time is 12-15 Hours
- Research current therapies
- Research initial drug compatibility
- Research logistics impact
- Research cost of APIs, cost to produce the product
- Deeper dive into patient needs for a satisfactory product
- Review how the product is compounded
- Review of the science of the formulations, competitive advantages
Formulation Development
Estimated Time is 10-12 Hours
- Compound product for initial compatibility and feel
- Send for potency testing
- Source APIs
- Teach technician teams to compound
- Compound batches based upon the number of patient sample sizes
Testing & Quality Assurance
Estimated Time is 5-7 Hours
Review formulation options and to determine whether or not to compound
If approved,
- Send test prescriptions to beta sites
- Research qualified practitioners
- Await feedback
- Adjust formulations if necessary and re-dispense for follow-up.
Study/Formulation Wrap-Up
Estimated Time is 2-3 Hours
Formula details are shared with provider or clinic. Provider or Clinic shares with a contract manufacturing organization (CMO), or keeps formula at Innovation Compounding to dispense to their patients.
Post Study/Formulation Consulting for CMO
This portion of the services is optional.
* R&D and Product Development services may require additional fees, contracts, and billable line items.
REQUEST A QUOTE OR MORE INFORMATION
Tell Us About Your Project
How can we help your team in their research and development project?
CONNECT WITH US
6095 Pine Mountain Rd. NW,
Suite 108
Kennesaw, GA 30152
(800) 547-1399 Ph.
(866) 635-2329 Fax
Hours:
9:00 a.m.-6:00 p.m. M-Th
9:00 a.m.-5:00 p.m. Fri