GlobalSubmit

GlobalSubmit

Certara
+
+

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About

Whether you are experienced or new to the regulatory submission process, the risk of rejection of your electronic common technical document (eCTD) submissions cannot be taken lightly, especially given the changing and growing complexity of the regulatory environment. Not to mention, differences in eCTD submission criteria per region, managing the entire document lifecycle and meeting your organization’s goals on expediting your release to market. With Certara’s GlobalSubmit™ eCTD submissions management software, you’ll provide your regulatory team the tools they need to efficiently publish, validate, and review your eCTD submissions. This means you can eliminate risk and avoid unnecessary steps with a simplified eCTD submission process that supports your regulatory team as they race to meet deadlines and deliver treatments to patients. As your regulatory department races to meet deadlines and deliver treatments to patients, it’s crucial that you file your eCTD submissions.

About

Samarind RMS provides a smarter way to manage your medical product information. Using Samarind RMS, you only need to enter data once and can reuse it as many times as required. For example an ‘INN’ can be entered once and reused for all related IMA submissions, renewals, variations, PSURs and XEVMPD submissions. This concept applies to all key data held within the system and is proven to streamline workflows and help to increase data quality. Our pragmatic approach to systems design and implementation means that our customers can manage their licenses smoothly and efficiently, safe in the knowledge that our single-place-of-truth™ approach for regulatory affairs professionals delivers a complete end-to-end system. An electronic document management system (EDMS) with version control, template creation and the ability to link to external document management systems such as Documentum™ or SharePoint™.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Companies seeking a solution designed to simplify complex regulatory processes

Audience

Enterprises searching for an integrated solution to mirror the processes associated with acquiring and maintaining product licenses

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Certara
Founded: 2008
United States
www.certara.com/regulatory-science/globalsubmit-ectd-submissions-software/

Company Information

Instem
Founded: 1969
United States
www.instem.com/solutions/samarind-rms/

Alternatives

BeeCTD

BeeCTD

Altamira

Alternatives

LICENSALE

LICENSALE

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LifeSphere RIMS

LifeSphere RIMS

ArisGlobal
RIMTrack

RIMTrack

WinWire Technologies
Ennov Doc

Ennov Doc

Ennov

Categories

Categories

Integrations

Microsoft SharePoint
OpenText Documentum

Integrations

Microsoft SharePoint
OpenText Documentum
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Claim GlobalSubmit and update features and information
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