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Electronic Submissions |
understanding compliance and validation issues
As a highly specialized form of document management, electronic submissions
has evolved from a competitive advantage to a base requirement for life
sciences companies. Requirements from the FDA and other worldwide regulatory
agencies continue to demand more and more sophistication within submissions.
Initially targeted at major marketing applications for drugs, these evolving
requirements will soon impact device and nutritional submissions.
When a single drug can be worth hundreds of thousands of dollars a day in
sales, companies must do everything possible to accelerate a submission and
the agency’s review. Put another way, companies must do everything possible
to avoid delays with a submission and the agency’s review.
Praxis has helped life sciences companies with a variety of projects, so we
understand the compliance and validation issues. Our project management
skills are second to none. We understand the executive and organizational
challenges faced with implementing major business changes, especially
electronic submissions. Also, we understand electronic submissions
processes and technologies.
Praxis Life Sciences offers an experienced team with a structured approach:
e-Submissions Leadership
- Program strategy development
- Business case development
- Program organization design
- Program management office (PMO)
- Vendor negotiations
People
- Executive and stakeholder alignment
- Executive and stakeholder communications
- Skill and behavioral change assessment
- Organizational change management
- Training
Process
- Future state process development
- Current state process assessment
- Gap analysis
- Process proof-of-concept workshops
- Requirements development
Technology
- Collaboration with key vendors (e.g. Documentum, CoreDossier)
- Systems definition
- Architecture design
- Build and test
- Validation and compliance
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