eCTD for Small & Medium Businesses

A single source solution for electronic common technical document submisssion. 

PhlexSubmission is a robust and easy to use publishing engine for electronic submissions such as eCTD, NeeS, VNeeS but it also does come with paper publishing capabilities for CTD and any custom type submissions that a customer might require. It is highly configurable from a submission type perspective.

 

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PhlexSubmission is the ideal solution for meeting Regulatory Requirements

IND

Investigational New Drug 

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DMF

Drug Master File

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CEP

Certification of Suitability

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What is included in the Annual Subscription?

 

Software and Support 

TMF Software

Software Subscription

  • Regulatory Operations Platform
  • Gateway Connector
  • Content Analysis Framework
  • Author User
  • Read User       
  •                     

 

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Software Maintenance

  • New versions
  • Bug fixing
  • Patches
  • Custom features
  • Compliance updates

 

 

 

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Support Services

  • 20/5 support availability
  • 1h guaranteed response time
  • Technical support services
  • Regulatory support services
  • Adhoc user training
  • Administrator coaching

Datacenter & Infrastructure

Database

Hardware and 3rd party SW

  • Primary server hardware
  • Backup server hardware
  • Server licenses
  • Database licenses
  • Data storage

 

 

Datacenter

Datacenter Operations

  • Periodic backup & recovery
  • Data security services
  • Antivirus services
  • Network intrusion detection
  • Firewall services
  • Database services
  • Performance scaling
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Regulatory Compliance

  • Server monitoring
  • Security patching
  • Database optimization
  • Regulation tracking & updates
  • On going validation
  • Installation qualification
  • Operational qualification
  •  
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Want to see it in action? 

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Phlexglobal provides eCTD Success

Others only provide tools

 

INCLUDED:

Software

Support

Maintenance

Microsoft Data Center

Compliance

Unique eCTD Features

  • Unlimited eCTD sequences
  • All eCTD regions included
  • PDF Rendition included
  • VERA – Virtual Electronic Regulatory Assistant
  • Document Management System (DMS) included

Software Maintenance

  • New versions
  • Patches
  • ICH compliance updates
  • Validated Environment:
    • Regulation tracking & updates
    • Security patches
    • Database optimization
    • Ongoing validation

Support Services

  • 20/5 support availability
  • 1h guaranteed response time
  • Technical support services
  • Regulatory support services
  • Adhoc user training
  • eCTD Compliance Guarantee

 

 

INCLUDED:

Success

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We don’t offer you just the software…we offer you success!

 

We have found that over 90% of our support calls are NOT related to the technology itself… they are almost always about regulatory concerned questions starting with: How, What, Why and Where.

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  • Our eCTD support experts help you at no additional charges
  • Call or write our global support team when you face eCTD challenges
  • Adhoc online eCTD Training included
  • We guarantee your eCTD compliance
eCTD for Small Business

IND in eCTD

Manage your INDs in eCTD format easily, quickly and with guaranteed compliance.

Investigational new drug or IND is an application to FDA (US Food and drug administration) by which a pharmaceutical company obtains a legal exemption to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

The IND Application must contain information in thee broad areas: Animal Pharmacology and Toxicology Studies; Manufacturing Information; Clinical Protocols and Investigator Information. Once the IND is submitted,the FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. 

IND submissions have been completely electronic since 5th May, 2018, which means that all necessary information must be submitted in eCTD format. This includes making sure that all your documents are submission-ready, you are able to create your IND submission as eCTD, and establishing your connection to the FDA via the Electronic Submissions Gateway (ESG). The INDs in eCTD format mandate subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect. 

Are you ready to submit your investigational new drug applications (INDs) in the eCTD format? Don´t risk many years of research with an unnecessary delay or refusal of your submission.
 

Be ready to submit your INDs in eCTD today with PhlexSubmission. 

 
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DMF in eCTD

Master your DMF easily, quickly and with guaranteed compliance!

A Drug Master File (also known as DMF) is a submission type that is used to provide confidential detailed information, such as facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs, to the appropriate regulatory authority.

While DMFs were usually submitted with none electronic submissions, recent development of regulatory authorities requires (or will require in future) to submit DMFs in eCTD format (electronic common technical document). Such requirements usually comes with the strict deadlines like most types of DMFs. For full US FDA guidance on electronic submissions please follow the link. Failing to submit your drug master files in eCTD could lead to failure of reaching customers due to suspended providers licence on that specific drug.

Were  you ready to submit your Drug Master Files (DMFs) in the eCTD format by 5th of May 2020? If not, we are here to help. Being ready means making sure your documents are properly prepared (bookmarked, OCR’d, proper orientation), you are able to create your baseline DMF submission as eCTD, and establishing your connection to the FDA (USA) via the Electronic Submissions Gateway (ESG). The DMF in eCTD format mandate applies to amendments, letters of authorization and annual reports… no exemptions, no waivers!

Phlexsubmission is built for this purpose and manages DMFs quickly, easily and with 100% of compliance!

Be ready to submit your DMFs in eCTD today with PhlexSubmission. 

 
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CEP in eCTD

Manage your CEP submissions in eCTD format easily, quickly and with guaranteed compliance.

Are you looking for the best software solution to submit your Certification of Suitability to the Monographs of the European Pharmacopoeia Applications (CEP software) in eCTD format? PhlexSubmission is built to help you prepare and submit your CEPs. A secure and easy to use solution that can get you started today. And our global Client Success team guarantees 100% eCTD compliance for your first CEP submission!

Were you ready to submit your Certification of Suitability to the Monographs of the European Pharmacopoeia (CEPs) in the eCTD format by January 1st 2020? According to the European Directorate for the Quality of Medicines & HealthCare (EDQM) – the organisation responsible for the procedure of CEP –  in order to receive EDQM Certificate submissions for CEP must be in the eCTD format beginning the 1st of January 2020.

The mandate applies to:

  • Notifications, revisions, renewals & new applications
  • EDQM will no longer accept NeeS Submissions for notifications, revisions and renewal application
  • Exceptions applies to TSE only submissions, where PDF continues to be a standard format accepted.

About CEP submission

CEP or Certification of Suitability to the Monographs of the European Pharmacopoeia is the certification confirming  that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to the monographs of the European Parliament.

Scope of the CEP:

  • “Chemical” or herbal” CEP – substances described in monographs: active substances, excipients, herbal drugs/herbal preparations
  • “TSE” CEP – products with risk of TSE (SM, intermediates, reagents)

CEP application:

CEP application in eCTD format contains 3 modules:

  • Module 1 – Application form and a dossier in eCTD format written in one of two official languages of Council of Europe (preferably in English)
  • Module 2 – Quality Overall Summary
  • Module 3 – Baseline. Holds the information of previous submissions.
    • Mandatory for the following circumstances:
      • switch from a paper to an eCTD
      • switch from a PDF/NeeS to an eCTD
    • Recommended for a renewal, a revision or a notification

Upon receipt, the application is validated and listed for assessment. After assessment, the EDQM may send queries to the applicant. When they are resolved, the EDQM sends the applicant a CEP certificate, which is valid for 5 years from the date of first issue and valid indefinitely following the 5-year renewal.

CEP application is open to any manufacturer regardless of region they are based at. CEPs are accepted in 36 Member States of the European Pharmacopoeia Convention + EU, Canada, Australia, Singapore, South Africa, etc.

If a company which has been granted a certificate of suitability (EDQM’s CEP) may wish to apply for another CEP for the same substance, either when it is not possible to apply for a revision of the initial CEP or when the company wishes to have separate CEPs for different conditions of preparation or qualities, they can submit a new application as a “sister file”. This new application should fulfill the conditions listed in the guideline for sister files.

Be ready to submit your CEPs in eCTD today with PhlexSubmission. 

 
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Unique Benefits for Phlexglobal Customers

 

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Cut submission time by 90 %

...through seamless integration of document management functionalities and submission tools, such as automatic creation of the submission tree, automatic document placement and web based sharing capabilities.  - „Autocompile“ function.

 

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Cut audit prep time by 90 %

...by leveraging automatic tracking of all training results across the organization. No Excel or Word report compilation required

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Increase working speed from hours to minutes

...via providing user with unique process optimization features.

(1)For example via a comfortable document sharing function, selective content can be shared securely and within minutes internally and externally.

(2) Parallel real time collaboration

 

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Project ROI 6 months or less

...by reducing the implementation time to hours instead of months.

This is made possible via industry best practices processes already implemented within the system instead of in project reenginereing.

This results in “One Click” deployment.

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Save  30-50% in license cost*

...through an innovative pricing concept  i.e. Value for Money.

Customers pay for value that the solutions helps to create (i.e. per submission) versus traditional per user models from existing vendors

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Lower maintenance costs by 70%

.Phlexglobal is implemented as a real multi tenant cloud systems. Customer data is strictly separated, all implementations are shared and all maintainance work is being shared by all customers as well. This reduces the maintenance costs to each individual customer.

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Get the Details - Download the eCTD Data Sheet

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It's time to raise your standard 

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