eWAY-eCTD SOLUTIONS is a web-based dossier creation and publishing tool designed to meet the ICH eCTD standard while also allowing for best practice processes to be employed. We meets the requirements in Life Science organizations where ease of installation, ease of use, regulatory compliance, and affordability are the primary business drivers.

We provide eCTD, DMF-eCTD, NeeS, VNeeS, SPL, R-CTD  format conversion services and solutions. We deliver the best quality services to our clients, regardless of the complexity of the requirements.

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD solution software for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry thought the globe.

eWAY-eCTD SOLUTIONS support all major eCTD accepting countries and for US (United State) dossier/submissions, Country/Agency Listed below:

US- (United States Food and Drug Administration-USFDA)

US Module 1 Specification, version 1.3 (DTD 2.01)

US Module 1 Specification, version 2.3 / version 2.4 (draft) (DTD 3.3)

US eCTD Validation Criteria, version 3.8 (draft)

ICH eCTD Specification, version 3.2.2

ICH Study Tagging File (STF), version 2.6.1

ICH M4 Organization of the CTD, October 2017

US eCTD Technical Conformance Guide, version 1.3

US PDF Specification, version 4.1

US File Format Specification, version 3.0

US Transmission Specifications, version 1.8

US Study Data Technical Conformance Guide, version 4.2.1

US Providing Regulatory Submissions in Electronic Format, Revision 6

EU (European Union)- European Medicine Agency-EMA

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

eWAY-eCTD SOLUTIONS solutions support all major eCTD accepting countries and for EU (European Union) dossier/submissions, EU (European Union) eCTD Suite is fully compliant with;

EU Module 1 Specification, version 3.0.3 (DTD 3.0.1)

EU eCTD Validation Criteria, version 7.1

ICH eCTD Specification, version 3.2.2

CA (Health Canada) 

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

eWAY-eCTD SOLUTIONS solutions support all major eCTD accepting countries and for CA (Canada) dossier/submissions, CA (Canada) eCTD Suite is fully compliant with;

CA Module 1 Specification, version 2.2 (DTD 2.2)

CA Preparation of Drug Regulatory Activities in the eCTD Format-2015

CA eCTD Validation Criteria, version 4.4

ICH eCTD Specification, version 3.2.2

GCC (Gulf Corporation Council) 

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

 eWAY-eCTD SOLUTIONS solutions support all major eCTD accepting countries and for GCC (Gulf) dossier/submissions, GCC (Gulf) eCTD Suite is fully compliant with;

GCC Module 1 Specification, version 1.5 (DTD 1.1)

GCC eCTD Validation Criteria, version 1.4

ICH eCTD Specification, version 3.2.2

ZA-MCC-SAHPRA (South Africa)

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

 eWAY-eCTD SOLUTIONS solutions support all major eCTD accepting countries and for ZA-MCC (South Africa) dossier/submissions, ZA-MCC (SAHPRA) eCTD Suite is fully compliant with;

ZA-MCC-SAHPARA Module 1 Specification, version 2.1 (DTD 2.1)

ZA-MCC-SAHPARA eCTD Validation Criteria, version 2.1

ICH eCTD Specification, version 3.2.2

AU (Australia)- Therapeutic Goods Administratio-TGA 

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

 eWAY-eCTD SOLUTIONS solutions support all major eCTD accepting countries and for AU (Australia) dossier/submissions, AU (Australia) eCTD Suite is fully compliant with;

AU Module 1 Specification, version 3.1 (DTD 3.1)

AU eCTD Validation Criteria, version 3.1

ICH eCTD Specification, version 3.2.2

CH (Swiss Medica) 

eWAY-eCTD SOLUTIONS has robust and fully compliant eCTD software / solutions for pharmaceuticals, bio-pharmaceuticals, healthcare and life-sciences industry.

 eWAY-eCTD SOLUTIONS solutions support all major eCTD accepting countries and for CH (Swiss) dossier/submissions, CH (Swiss) eCTD Suite is fully compliant with;

CH Module 1 Specification, version 1.3 (DTD 1.3) – Valid till June 30, 2019

CH Module 1 Specification, version 1.4 (DTD 1.4) – Must from July 01, 2019

CH eCTD Validation Criteria, version 1.3 – Valid till June 30, 2019

CH eCTD Validation Criteria, version 1.4 – Must from July 01, 2019

ICH eCTD Specification, version 3.2.2

Thai-FDA (Thailand)- Food and Drug Administration- Thailand 

Thai FDA (Thailand) plan to accept dossier in eCTD format: The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptance of Pilot eCTD from October 2014.

Authority has scheduled to receive the eCTD submission from May 2015.

eWAY-eCTD SOLUTIONS is unique software, which is fully compliant with Thai-FDA Module 1 Specification, version 1.0 and Validation Criteria version 1.0, will be required by Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptance of eCTD from May, 2015.

JO-FDA (Jordan)-Jordan Food and Drug Administration- JFDA

In Jordan submission is accepted in eCTD format. eWAY-eCTD SOLUTIONS, is fully compliant with JO-Module 1 Specification (v1.1) and Validation Criteria (v1.0), as required by Jordan Food and Drug Authority-JFDA. JO-FDA eCTD Software : eWAY-eCTD SOLUTIONS is a comprehensive submission management system with Dossier life cycle management.United States Food and Drug Administration