Ulick is very experienced at validation preparation and execution of medical device processes, and preparation of all required documents – plans, protocols, reports, FMEAs etc.

Ulick is a very experienced at preparing submissions for label changes for regulatory authorities for medical devices and disinfectant products with the US FDA, EPA and European Medicines Agencies. Submission have been prepared for new products and updates for existing products to add additional claims, CAPAs (Corrective and Preventative Actions) and related issues.

Ulick can also provide GMP (Good Manufacturing Practices) training and training on a variety of Engineering and Production topics including Brainstorming, Job Breakdown Sheets, GMP Documentation and ISO 9001.

Please submit your query and Ulick will assess the issue at no cost and provide costings for alternative paths to address the issues.