The Group uses our internal resources and expertise to develop pharmaceutical products from the "lab to the loading dock." Logical deduction based on previous delivery systems formulation with known actives has yielded human trials in as little as four months for some clients. In the past, we have developed formulations (including scale up and clinical/NDA batches) for human Rx and vet products.
Formulation examples include:
* Oral delivery of Rx protein; formulation assistance, new delivery design and scale up.
* MDI reformulation; component compatibility, dose to dose uniformity, patient use trials, release testing, failure analysis, and system improvement.
* Vaginal Rx suppository; formulation assistance, scale up, and clinical trial batches.
* Sustained release Rx corticosteroid; formulation, scale up, and clinical trial batches.
* Topical aqueous-based Rx cream; packaging design, clinical trial manufacturing management, and analytical method design.
* Nasal delivery of recombinant peptide; formulation and clinical batches.
* Buccal delivery of opiate for acute pain management; pre-formulation and clinical trial batches.
* Controlled release; steroids, corticosteroids, friendly bacteria.
* Topical wound; formulation, scale up, and system improvement.
* Micro-encapsulated active; formulation assistance, taste masking, and texture control.
Manufacturing support, Problem solving, Validations, and Failure Analysis
McCoy Enterprises LLC. is a hands-on team. Our practical knowledge and approach form a unique view of a problem or project. By initially using low-tech approaches to find the right path, we have saved several customers hundreds of thousands of dollars. We have been able to find low-cost, practical solutions by assembling teams of manufacturers, engineers, and scientists with extensive corporate backgrounds.