EXTEDO Regulatory Software Solutions for Life Sciences

Time 2022-09-28 18:44:16

Web Name: EXTEDO Regulatory Software Solutions for Life Sciences

WebSite: http://www.extedo.com

ID:332608

Keywords:

Software,Regulatory,EXTEDO,Solutions

Description:

ENCNmyEXTEDO LoginCareersSoftwareServicesSupportBlogEventsResourcesCompanySoftwareOverviewEXTEDOpulse OverviewEXTEDOpulse PlansPlanning and Tracking HubWrike for Life SciencesDocument Management HubeDOCSmanagereCTDtemplatesProduct Registration HubMPDmanagerSubmission Management HubeCTDmanagereSUBmanagerPlantOSEURSEURSvalidatorSafety Management HubSafetyEasyServicesRegulatory Publishing ServicesBusiness Process and Regulatory ConsultingPharmacovigilanceeCTD ServicesEURS ServicesBusiness Process and IDMP ConsultingIDMP Pre-Collection Service PackageIDMP ServicesTechnical ConsultingEducation and TrainingeLearningInstallation and Validation ServicesExtended Support ServicesSupportEXTEDO Customer SupportBlogEventsResourcesCompanyAbout EXTEDOManagement TeamCustomer ReferencesIndustry Customer ReferencesRegulatory Agency Customer ReferencesLocations and ContactCareersCertifications and MembershipsEXTEDO PartnersEXTEDO Partners Listing by CountryProfessional PartnersConsultant and MAF PartnersTechnology PartnersPartner ProgramNewsSubscribe for EXTEDO MailingsSubscribeUnsubscribeSoftwareOverviewEXTEDOpulse OverviewEXTEDOpulse PlansPlanning and Tracking HubWrike for Life SciencesDocument Management HubeDOCSmanagereCTDtemplatesProduct Registration HubMPDmanagerSubmission Management HubeCTDmanagereSUBmanagerPlantOSEURSEURSvalidatorSafety Management HubSafetyEasyServicesRegulatory Publishing ServicesBusiness Process and Regulatory ConsultingPharmacovigilanceeCTD ServicesEURS ServicesBusiness Process and IDMP ConsultingIDMP Pre-Collection Service PackageIDMP ServicesTechnical ConsultingEducation and TrainingeLearningInstallation and Validation ServicesExtended Support ServicesSupportEXTEDO Customer SupportBlogEventsResourcesCompanyAbout EXTEDOManagement TeamCustomer ReferencesIndustry Customer ReferencesRegulatory Agency Customer ReferencesLocations and ContactCareersCertifications and MembershipsEXTEDO PartnersEXTEDO Partners Listing by CountryProfessional PartnersConsultant and MAF PartnersTechnology PartnersPartner ProgramNewsSubscribe for EXTEDO MailingsSubscribeUnsubscribemyEXTEDO LoginCareers

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Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences

EXTEDOpulsesupports the critical relationship between the pharmaceutical industry and regulatory authorities, ensuring that your life sciences business operates a compliant and efficient product registration and maintenance process.

Planning & Tracking Hub

Document Management Hub

Product Registration Hub

Submission Management Hub

Safety Management Hub

"eCTDmanager´s incredibly user-friendly interface and intuitive design enabled us to operate without dedicated IT support. The EXTEDO team was remarkably supportive, effective and professional throughout our cooperation!"

Regulatory Affairs Director atGuangzhou Henovcom Bioscience Co. Ltd

Learn more about EXTEDO eCTDmanager

"EXTEDO is a great example of a company that really understands the requirements of the market"

Director Business Development, Technical Operations and International Business at Genericon

Learn more about EXTEDO

"Since the EXTEDO solution is easy to use the training process went smoothly. We were working on compiling dossiers almost immediately after the installation."

Quality Assurance & Regulatory Affairs Manager at PHF SA

Learn more about our training offerings

EXTEDOpulse for Regulatory Information Management and eCTD

EXTEDO‘s focus is on optimizing clients‘ eRegulatory business processes. EXTEDOpulse is a complete Regulatory Information Management System (RIMS), including Planning & Tracking, DocumentManagement, Product Registration, Submission Publishing & Lifecycle Management, and Safety Management.

Solutions For Large Companies

EXTEDO helps large life sciences companies navigate the complex regulatory landscape involved with developing and managing hundreds of products across multiple geographic regions.

Solutions for Small Companies

EXTEDO provides solutions covering the entire regulatory landscape. Through this unique approach EXTEDO supports small companies and CROs with off-the-shelf software and services designed around common business and regulatory needs.

Solutions for Regulatory Agencies

For many years EXTEDO has collaborated with regional agencies to ensure compliance with the latest regulatory standards. Our reviewing and validation solutions are used by over 35 regulatory agencies worldwide.

Latest blog posts

The EMA published the FHIR Conceptual Data Model (CDM)

Updated excel file now available on the DADI website

Read more

US FDA Adverse Event Reporting System (FAERS) Electronic Submissions

Is the US Food & Drug Administration in final preparations for switching to E2B(R3)?

Read more

EMA Publishes New Timeline For DADI Project

Updated DADI Human Variations Form Timeline and revised go-live scope

Read more

US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B (R3) Standards

US Food & Drug Administration announced that they adopted the ICH E8(R1) guideline on general considerations for clinical studies.

Read more

CMDh Updates Guidelines to Implement Northern Ireland Protocol (Brexit relevant information)

Updated practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DC

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US FDA announces that DTD version 3.3 will be made mandatory for eCTD submissions

US FDA announced the requirement for Electronic Common Technical Document (eCTD) Module 1 U.S. Regional DTD Version 3.3 starting from 01 March 2022.

Read more

See more blog posts

Upcoming Events

Webinar 2022-09-29

Complimentary Webinar: The Reuse of Data - How to use eCTDmanager more efficiently

In this webinar, you will learn more about using specific functionalities within eCTDmanager to reuse data and documents when managing multiple…

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Tuttlingen (Germany) 2022-10-06

Info Market: Digital RA & QM-Solutions

Whether it's technical documentation or risk assessment, how would it be if tasks like these could be completed faster and more efficiently?

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Webinar 2022-10-13

Complimentary Webinar: Implement a Master Quality Management System: How can you eliminate uncertainty and prepare stakeholders?

Life sciences organizations need to balance easy access to data, fast internationalization and operational efficiency with product quality and risk.…

Read moreSee more events

SOFTWARE SOLUTIONS

EXTEDOpulse Product Overview
Planning &Tracking Hub
Document Management Hub
Registration Management Hub
Submission Management Hub
Safety Management Hub

SERVICES

Business Process and Regulatory Consulting
Technical Consulting
Education and Training
Installation and Validation
Extended Customer Support

HEAD OFFICE

EXTEDO GmbH
Einsteinstrasse 30
85521 Ottobrunn (Munich area)
Germany

Directions

All office locations

CONTACT

EXTEDO Germany: +49 89 189454-0
EXTEDO US: +1 (855) 328-3500

info@extedo.com

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