Whether you're creating your first submission or addressing a unique issue, there's a service offering to meet your needs, including:

• Submissions Planning including resource planning, submission tools and vendor evaluation, staff augmentation and process improvement
• Submissions Tracking including project management, status monitoring and workflow setup
• Conversion Services for eCTD and SPL/PIM Labeling including LCR and ERF
• Assembly & Publishing for paper to electronic, PDF Generation and eCTD to paper
• Quality Control including document validation checklist, submission validation checklist, proofreading and word-to-word comparison
• Transmission through the FDA electronic gateway
• Submission Archival including document management system setup

Put SLP's deep submissions experience and knowledge to work for your organization.