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.

 
Custom medications. Optimal Outcomes.

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 becomes IRC’s property. IRCs shares with a contract manufacturing organization (CMO).

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.

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Tell Us About Your Project

How can we help your team in their research and development project?

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Our staff is full of compassionate health care professionals ready to counsel practitioners and patients alike. We’re here to listen to you, research your needs, and provide you with not only medication, but also the knowledge to reach your desired health goals.

Information contained on this site is provided as an informational aide and for reference use only. The content herein is not intended to be, act as, or replace medical advice or diagnosis for individual health conditions nor is it making evaluations as to the risks or benefits of particular preparations. Please consult a licensed healthcare professional about diagnosis and treatment. Information and statements on this site have not been evaluated by the Food and Drug Administration.

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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

   

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