Proposal for ectd Products & Services. Antoinette Azevedo President & CEO e-submissionssolutions.com President Sage Submissions 17 October 2016 Final

Transcription

1 Proposal for ectd Products & Services Antoinette Azevedo President & CEO e-submissionssolutions.com President Sage Submissions 17 October 2016 Final

2 IPEC-Americas RFP IPEC-Americas members are interested in learning if your organization would consider offering either a fixed rate or a percentage discount (as appropriate) for ectd conversion services/conversion software for IPEC-Americas member companies... [to meet the] time lines for conversion of paper Master Files to electronic ectd format. [T]he US FDA s regulation is scheduled to go into effect May 17*, *deadline is May 5, 2017

3 ectd Creation & Submission Process 1. MS Word skills & templates 6. Electronic Submission Gateway (ESG) 2. Adobe Acrobat PDF conversion Compliant ectd submission 5. ectd compilation & Validation 3. Adobe Acrobat PDF remediation tools & skills 4. Secure content repository (EDMS or file share); 21CFR11

4 IPEC-Americas Proposal Options For Sage Templates for ectd FDA DMFs Module 1 Health Canada DMFs Module 1 Module 2, 3, 4 MS Word Legacy Reorganization to ectd Format MS Word & PDF Remediation Services ectd Publishing Services for FDA and HC DMFs ectd Validation Services for FDA and HC DMFs Consulting Services to Implement Secure with FDA Electronic or Digital Signature FDA ESG production account may be used to submit to FDA and HC ectd Submission via Consultant s ESG Production Account

5 IPEC America ectd Products and Services - FDA secure - Electronic or Digital signature - Digital Certificate (s) - Implement production account Or - Submission via Consultant s production account Consultant s licenses for: - LORENZ docubridge for FDA & HC DMFs - LORENZ evalidator for FDA & HC DMFs - GlobalSubmit Validate+Load and Review 6. Electronic Submission Gateway (ESG & CESG) 5. ectd compilation & Validation RegDocs365 with EDM Reference Model configuration for DMFs 1. MS Word skills & templates Compliant ectd submission 4. Secure content repository (EDMS or file share); 21CFR11 2. Adobe Acrobat PDF conversion 3. Adobe Acrobat PDF remediation tools & skills Sage Templates for FDA & HC DMFs MS Word Processing Services Adlib PDF Enterprise server with RegDocs365 Consultant licenses for - Adobe Acrobat Pro - TRS Toolbox Pharma Edition All components hosted at Sungard facility in Marlborough, MA managed by Court Square Group

6 Companies in Proposal Antoinette Azevedo, President Sage Submissions Mobile % owned by e-submissionssolutions.com California s corporation Began offering Sage Templates in 2007 Antoinette Azevedo, President & CEO e-submissionssolutions.com Mobile aazevedo@regdocs365.com 100% owned by Antoinette Azevedo California s corporation Began offering consulting services 2000 Began offering publishing services 2005

7 The Proposal Assumptions IPEC-Americas members who wish to outsource all or part their ectd publishing IPEC-Americas members who desire a range of products and services to prepare ectd submissions for FDA and Health Canada Offered in parallel with Joint Venture unique/total solution Could provide services to IPEC-Americas members who opt for Joint Venture but wish any of the following: ectd training Legacy DMF to ectd reorganization/word processing MS Word remediation PDF remediation ectd publishing using Member license in Joint Venture FDA & HC ectd validation FDA & HC ESG/CESG implementation consulting Electronic signatures consulting Submission via Consultant s ESG production account FDA & HC

8 The Proposal Sage Templates for FDA or HC DMFs Upfront purchase Enterprise license 25% discount deducted on bottom line of invoice Services - 25% discount from standard pricing deducted on bottom line of invoice Sliding scale for IPEC-Americas members who require publishing of lots of LOA submissions

9 Sliding Scale for High-Volume of LOAs $500 1 LOA submission/month $1,200 3 LOA submissions/month ($400 each) $1,500 5 LOA submissions/month ($300 each) $1,750 7 LOA submissions/month ($250 each) Assumptions 4 pages/submission Submission-ready PDF files; if revised or noncompliant revert to time & materials charges Files named according to pre-defined standards No external hyperlinks

10 Questions Antoinette Azevedo Tel