Why HartmannWillner is the Answer to Your eCTD Publishing Dilemma
We have the ability, access, and experience other organizations do not. Let us help you achieve your eCTD publishing goals.
Table of Contents:
- How we can help you achieve your eCTD publishing goals.
- What eCTD Publishing Services and eSubmission Capabilities we can offer you.
- Our checklist for ensuring your PDF documents are in compliance and ESG submission ready.
- How we use electronic signatures for your convenience.
- Obtaining a FDA ESG Account- why letting us help you will save you time, aggravation, and costs.
- How our Microsoft Word templates ensure your documents are eCTD ready.
- How we provide you support throughout the eCTD publishing services lifecycle.
How we can help you achieve your eCTD publishing goals
To confidently compile FDA compliant electronic regulatory submissions, it takes many years of training. Many organizations do not have the ability to accomplish this. This is where we can be the answer to your electronic Common Technical Document (eCTD) publishing situation or dilemma.
Our experience and knowledge:
- Working at the US DOD, US FDA and US HHS
- Long standing memberships and relationships in RAPS and DIA
- Published and submitted hundreds of successful submissions to the FDA.
Our eCTD Publishing Services will:
- Lead you through the maze of regulations, guidances, rules, and best practices
- Compile and publish a compliant original eCTD submission or to perform submission maintenance (amendments and supplements)
- Offered is our assistance to you during times of unexpected workload peaks or during unplanned staff absences.
We are flexible and will do what is necessary to get the job done!
Why outsourcing maybe your best option:
Your organization may be a small to mid-sized business with circumstances where outsourcing submissions and eCTD publishing services could be particularly beneficial. A few of these scenarios may be:
- You have overwhelmed staff; your regulatory team with competing priorities
- You have multiple submissions to be filed in a short time frame
- You must establish an ESG account
- You have team members with CTD regulatory affairs experience, but little to no eCTD experience
- You need to convert paper to electronic format
- Your eMDR (electronic Medical Device Reporting) closing in on due date
- Training your current personnel or hiring new personnel is required
Our CTD Regulatory Affairs team uses:
- Lorenz docuBridge: an efficient, accurate and automated eCTD publishing process.
- Lorenz eValidator: software to verify the input and accuracy of each submission. This is the same software the FDA proposes to use in their future platform.
Our CTD Regulatory Affairs team approach to preparing and submitting eCTDs begins with knowing the customer – you!
We take the time to understand your needs:
- We use our relationships to ensure that we understand your needs completely before launching off on the project.
- Our CTD Regulatory Affairs team meets and discusses the strategies, submission timelines(s), and risks associated with your project.
- Once the details are nailed down, all information is written up, reviewed, and then ultimately placed in our secure document management system.
Our CTD Regulatory Affairs team provides the following services:
- Regular communications and updates to the project status
- Resource allocation and management for all publishers involved
- Generate and update the eCTD Submission Tracker that identifies each component and tracks status at the file level
- Generate and update the Issues Log to track issues through to resolution at the file level
- Overall project risks and issues are tracked and communicated in monthly status reports
- Review of all project components for eCTD readiness
- Deficiency reporting on eCTD related issues
- Act as technical contact to FDA for submission related inquiries
What eCTD Publishing Services and eSubmission Capabilities we can offer you.
eCTD Submission Strategies
|We have the experience to put together a submission strategy that is in line with your organization’s wishes, needs and goals. We have assisted our clients with hundreds of submissions to date.|
eCTD Submission Timeline(s)
|We understand the importance of keeping your submission on track. This task is accomplished by using our eCTD Submission Tracker that identifies each component and tracks the status at the file level of your submission. This tracker is updated daily and shared with you.|
eCTD Compile, Quality Review, and Validate
|We perform several quality reviews to validate and ensure your submission is accurate and ready for submission through the Electronic Submission Gateway (ESG).|
eCTD Lifecycle Project Management
|We offer regulatory submission and eCTD publishing services for pre-marketing and marketing applications, as well as subsequent lifecycle submissions (amendments, supplements, reports, and meeting requests and packages) in support of those applications.|
Import and Clone eCTD Application(s)
|We are capable of importing and cloning submission(s) to maintain and support the lifecycle of your application.|
Our checklist for ensuring your PDF documents are in compliance and ESG submission ready
We ensure PDF compliance by following the FDA eCTD Data Standards, Portable Document Format (PDF) Technical Specifications Document.
Our checklist to ensure all documents are ESG submission ready:
Creating PDF Documents and Images
|Current guidance and instruction for scanning images at the proper resolution|
|Document file names are spelled in lower case with minimal use of hyphens and underscores|
|All non-standard fonts are fully embedded, sized appropriately and are from the List of Standard Fonts Black is the font color used except for hyperlink text, which will be blue in color|
|Navigation Tab is set to Bookmarks Panel and Page Magnification is set to “Default”|
|Current guidance and instruction for labeling and advertising materials|
|Table of Contents, hyperlink text, and bookmarks all function properly Opening links are set to open in new window Magnification is set to Inherit Zoom|
|Page numbers correspond from hard copy to PDF|
|All pages within the documents are in the correct orientation when viewed|
Page Size and Margins
|Printed area for pages fits for paper 8.5 x 11, including headers and footers so that text is not lost on printing or binding|
Scanned Images and Documents
|Image-based PDF or scanned documents will be converted using the Adobe Optical Character Recognition (OCR) Converted text and images are complete and accurate|
|Additional security is not activated in the settings or is password protected|
|Version is readable by Adobe Acrobat x|
|Files created from source documents use the “Optimize the PDF for Fast Web View” option|
How we use electronic signatures for your convenience
We have chosen and obtained GlobalSign Certificates as our authentication, security, and identity for eCTD submissions, encrypted FDA emails, and signing completed FDA forms.
Obtaining a FDA ESG Account- why letting us help you will save you time, aggravation, and costs
Establishing your own ESG account can be painful and expensive. There are many steps that you must go through to obtain a FDA ESG Account.
- Decide on a Web Trader or an AS2 Account
- Request an account (memo to FDA)
- Conduct the preparatory activities – obtain your electronic signature certificate, make sure that it works on your system
- Set up a Test Account – create a “test” submission
- Set up and configure your system (having an IT Department is helpful)
- Send in your “test” submission
- Obtain your “Production Account” approval
- Track your Submissions
Save time, frustration and costs by letting us help you through this process.
The benefits of outsourcing your submissions to us are numerous; just the time alone saved will enable you to concentrate on other tasks.
Need to enroll in the eMDR Program? Save time, costs, and frustration by letting us help you.
We have already gone through the efforts to establish an eMDR (electronic medical device reporting) account. All you have to do is send us the pertinent information and we’ll take care of the rest. Your regulatory staff will not have to stress over meeting reporting deadlines.
Our secure email and fax account with the FDA.
We also have a secure email account with the FDA and a secure facsimile (fax) account. Any communication that needs to be secure can be accomplished through one or any of these methods.
How our Microsoft Word templates ensure your documents are eCTD ready
We have a Microsoft Word document templates repository in eCTD format for FDA compliant submissions. These templates can be customized for you and are eCTD ready for any type of submission, such as:
- Form FDA 3500A (MedWatch)
How these eCTD Publishing templates ensure success:
- They ensure that a developed and established Style Guide is utilized to consistently apply attributes to each line of text; fonts, paragraph spacing, indents, bullets, table text, etc. are consistent throughout the documents.
- They ensure that headers and footers styles look the same from page to page whether printed or on screen; page orientation is automatic, and proper margins are set.
- They ensure the Table of Contents Summary; Table of Tables, Figures and Appendices all work as they should and that all hyperlinked sections, tables, figures, references, and appendices point to the correct location within the documents.
How we provide you support throughout the eCTD publishing services lifecycle
We can provide continued support for all future sequences of your application(s), including:
- Transitioning from paper submissions to compliant electronic submissions in eCTD format.
- Maintaining submissions throughout the eCTD publishing services lifecycle.
- Granting you access to a secure and reliable communication transmission to the FDA through our ESG account, email accounts, or facsimile account.
- Maintaining your files in a secure document management system with a secure, password protected server.
- Converting legacy paper submissions and non-electronic submissions through scanning services and document management services into compliant eCTD documents.