|
Legal and Regulatory Support Ensuring all your labeling is in accordance with FDA requirements
Universal Graphics is your partner for legal and regulatory support. Consider us as an extension of your Regulatory and Q/A groups. We work diligently to develop an open communication relationship with you and your team to ensure your product labeling maintains its integrity at all times.
We have the experience and knowledge to guide your team through the “red tape”. Our staff has worked with clients for years in the healthcare industry to design bottles, cartons, labels and package inserts.
Product Labels and Inserts Universal Graphics’ in-house Product Development and Regulatory Labeling Division manage all aspects of product labeling, assuring that each component is in accordance with requirements set forth in CFR Title 21 and in compliance with current good manufacturing practice (cGMP) requirements.
Regulatory Tracking We know that regulatory tracking and reporting is an essential aspect of any compliance program. We maintain version control on-line and off-line as well as a full paper trail for all communications about your product.
Product Packaging Our staff are experts at creating product packaging. We have the creative skill to make it identifiable and know what is required by the FDA to be compliant. We offer advise and guidance to teams with new products coming to market.
Software Training Universal Graphics offers training on all the Microsoft Office products or other software. We can do basic training for your staff or we could create a customized training program (based on your specific needs). Training can be done in-person or via a web conference - you make the choice. Our trainers have over 25 years of individual experience working and training with the Microsoft Office Products and other software.
Our Staff Has Been Supporting the Healthcare Industry for Years Universal Graphics’ staff has over 150 years of combined experience supporting the healthcare industry. Several of our key staff members have worked in regulatory and legal for major pharmaceutical companies prior to joining Universal. They understand the legal and regulatory issues and keep abreast of the latest healthcare news and developments.
Our clients include large healthcare companies (animal health, consumer and pharmaceutical divisions), biotechs, CME providers and other healthcare industry companies.
|