KnowlegeNET is completely integrated regulatory compliant solution that complies electronic submission of dossiers in eCTD format effortlessly for all regions and provide eCTD Service for compilation and publishing.
Sarjen helps its clients accelerate innovation and increase their ROI considerably in R&D and provide quick and intuitive construction of complex electronic submission for any regulatory authority. It provides a simple and an easy-to-use user interface with multiple regional support that includes US, EU, Canada, GCC, ZA, JO, TH and CH etc. with multiple parallel users.
Sarjen is one of the very few software vendors vantage with intellectual and effective strategic corporate level consulting and has considerable number of successful submissions of eCTDs, NeeS, eDMFs, ASMF, etc. to its credit. Geared up with an integrated validator, which provides accuracy, efficiency and robustness to the cumbersome submission process. The constant consultancy that Sarjen provides makes your submissions furthermore easy.
With a comprehensive knowledge of global Regulatory publishing trends and submission formats (for example eCTD/Non-eCTD electronic submissions [NeeS]), Sarjen supports multi-country filings, data compilation, data publishing and dossier dispatches. For faster, compliant, seamless submissions, Sarjen offers an in-house eCTD publishing and submission management software which adheres to the regional and ICH standards.
Sarjen provides global eCTD submission format services are:
|Health Authority||Application and Submission Type||Submission Format|
|Food and Drug Administration (FDA) USA||IND, NDA, ANDA, BLA, DMF, Structured Product Labeling (SPL) Submissions, Originals, Amendments, Annual report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), eCTD baseline Submissions, eCTD Submissions for lifecycle management (LCM)||eCTD|
|European Medicinal Agency (EMA)||MA, Clinical Trial Application (CTA), Originals, Variations, Renewals, ASMF, CEP, PSUR with Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP)||eCTD|
|Health Canada||NDS, SNDS, ANDS||eCTD|
|Swiss Medic||Initial submissions, Responses, Variations||eCTD|
|GCC||MA, Renewals of MA, PSUR, Variation Type 1, Variation Type 2||eCTD|
|SAHPRA (South African health Product Regulatory Authority) [formerly known as MCC]||Initial submissions, Responses, Variations||eCTD|
|Thailand Food and Drug Administration||Initials, Amendments||eCTD|
|Australian Therapeutic Goods Administration (TGA)||Market Authorization Application (MAA)||eCTD/ NeeS|
|Jordan Food and Drug Administration (JFDA)||Baseline Submissions, Initial Market Authorization||eCTD|