Consulting Services:

The consequences of non-compliance with FDA, ISO, or EN regulations can be disastrous to a company's reputation and profitability. The Mycoscience consulting team can help you avoid costly regulatory pitfalls and market delays. Our expertise with FDA regulations, combined with extensive laboratory skills, enable us to analyze your product line and plot a comprehensive, economical course for your products from development through manufacturing.

MycoScience offers a variety of specialized consulting programs including sterilization and packaging guidance, validation protocol development, validation support, environmental control, as well as FDA submissions and simulated FDA audits.

• 510K, IDE, PMA Submissions
• QSR/ISO Training & Mock FDA Audits
• QA Systems and Design Review
• Sterilization and Packaging Validations
• Laboratory Consultations and GLP Audits
• Process Validations