EXUBERANT supports its clients' regulatory compliance efforts with comprehensive expertise in Part 11, pharma covigilance, computer systems validation and qualification, lab equipment and process control validation as well as enterprise application software implementation.

EXUBERANT's Life Sciences Practice (LSP) specializes in regulatory compliance and information technology support for the pharmaceutical, biotechnology and medical device industries. LSP services are specifically designed to mitigate risk and reduce time to deployment.

Our clients benefit from:

• Knowledgeable and team-oriented project managers and analysts
• An ability to approach virtually any technology with expert personnel
• A “brain trust” type of environment that can assist with almost any question in the realm of computer validation, Part 11, and computer system testing
• A customized approach to meet individual client requirements
• Clear, well-organized, and defensible SOPs, validation reports, testing reports and other documentation to meet the most stringent regulatory requirements

The following diagram depicts the areas of the drug development and delivery life cycle that EXUBERANT supports with its various service offerings. Immediately proceeding Discovery, EXUBERANT maintains a complete suite of services aimed at supporting the needs of its clients.

• Validation Master Planning
• Gap Analysis and Remediation Plan
• Risk and Compliance Assessments
• Validation Protocol Development
• Test Script Writing and Execution
• Final Report Documentation
• SOP Development
• Change Control Procedures
• Validation Training