SUBMISSION MANAGEMENT
Regulatory submission management is a complex process that is part art and part science. The WAYS team makes it look easy. We partner closely with our client teams, by taking care of the entire process or fill specific resource gaps so our clients can focus on innovative science. WAYS Pharmaceutical Services, Awarded 2022 Top Regulatory Services Companies by Life Sciences Review
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Organization
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Timeline management
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Develop and manage content plan
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Clearly define responsibilities / communication plan
Compilation
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Manage issues from identification through resolution
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Track and manage version control challenges
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Leverage technology where appropriate
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Employ best practices to produce process efficiency
Publishing
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Manage content plan against agency requirements
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Analyze and publish submission components and interpret guidance requirements for each
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Apply practical knowledge of validation criteria
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Use enabling technologies to verify compliance and view the final output
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Manage process that is informed by practical experience and driven by best practices
Dispatch
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Obtain signing certificate for the FDA Electronic
Submissions Gateway (ESG) -
Submit premarket and postmarket regulatory information for FDA review
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Manage gateway receipts for clients
Maintenance
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Understand and communicate agency deadlines
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Respond quickly and efficiently to present challenges, opportunities, and options


