Project Management
Evaluation & Development of Business Strategies within Regulated Environments
Quality Assurance Program Development or Management
Sterilization Program Management
(Ethylene Oxide, Radiation, & Steam as well as new technologies)
Sterilization Process Optimization and IFU Validation
Product Sterilization & Distribution Strategy Development
Validation Program Development & Execution -- Clean Rooms, Packaging, & Sterilization
Pre and Post Market Clinical Literature Reviews to support Risk Management Programs
Documentation or SOP Reviews & Preparation
Regulatory Action Resolution
Consulting services may be quoted by the project, activity, day or by the hour. Retainer contracts are also available. Please call or write for more information. |