Our Services

Pharmaceutical Regulatory Guidance

We understand that delivering superior pharmaceutical regulatory services that exceeds your expectations of performance is only part of what you have a right to expect from us. At Intagras, we make superlative service the other half of our client-centric equation and offer regulatory and submission guidance. We are invested in your success, and offer an array of services enabling us to assist you in truly meaningful ways. Our expert staff members are regulatory consultants and are more than willing- and more than able- to help solve your electronic submissions related concerns and issues. We work to ensure your complete satisfaction with our products, our services and our people.

Managing product labeling within the pharmaceutical industry is a complex task made even more difficult by the necessity of maintaining compliance with health authority requirements, depending on the global reach of your organization. Since 2005, pharmaceutical regulatory agencies have continued to expand electronic submission requirements. Current draft guidance continues to show that pharmaceutical regulatory agencies will only continue to expand and leverage the capability of electronic submission.

With the number of documents required for each of your products growing, and the sheer volume of information and data appearing on each document, reducing the complexity and cost of managing your global content becomes a crucial strategic decision. This is especially true if your organization is bound to Microsoft Word file formats, which will become increasingly more cumbersome as the demand for electronic submission formats grows. These are best handled through product labeling software tools facilitated by the flexible and powerful development environment XML makes possible.

Whether your labeling concerns lie strictly at the door of your in-house labeling department or they span the globe, Intagras can help. As a leader in developing and deploying structured content software and applications, we are invested in the success of our clients. We fully understand the scope of global regulatory requirements.

To find out more about Intagras solutions or to learn about Intagras as FDA submissions consultants for pharmaceutical labeling, call (813) 226-1863 to schedule a demonstration.