What is eCTD?
Regulatory requirements
Regulatory publishing trends and submission formats Marti Farm can support dossier submissions across the globe.
under the Decentralised procedure (DCP)
under the Decentralised procedure (DCP) in 2015 and new MAAs under the Mutual Recognition procedure (MRP) in 2017.
Why Use eCTD?
lifecycle tracking element, being a central archive of all submissions. The current view and lifecycle features gives the viewer the ability to quickly and unambiguously determine what is currently registered for a particular product, as well as showing when and what changes
Be prepared for dossier e-submission!
- Transition paper, NeeS or other e-format into eCTD
- Prepare your medicinal product documentation for upcoming regulatory changes:
- Document digitalisation
- Rendering (generating images)
- Document tags
- Hyperlinks
- Compliance with eCTD specifcations, e.g. PDF version, fle size, fonts, page numbering, review, protection etc.
Marti Farm expertise
- Developing and maintaining the process of capturing and documenting the regional Health Authority (HA) requirements
- Develop knowledge repository for regional and global requirements
- Periodic training and updates on the ever-changing global Regulatory requirements
- Gap analysis and creation of process aids, charts
- Continuous project monitoring
- Periodic quality check for effective time management
- Detailed tracker creation to track all the version changes made through publishing lifecycle
Our comprehensive eCTD services include:
- Project management of all regulatory submissions
- Formatting and editing of regulatory documentation
- Preparation of documents and references for submission
- Verifcation and insertion of appropriate document hyperlinks
- Initial submission of IND, NDA, ANDA, BLA, & Drug MasterFile (eDMF) submission and maintenance
- Preparation and publishing of amendments and supplements
- Communication with regulatory agencies
- Country-specifc composition, publishing, and validation for submissions in the EU, USA and Japan
- Utilization of our cloud-based software portal to ensure accurate and timely submissions
- Document authoring and medical writing services
There are numerous benefts to creating and managing eCTD submissions:
- Filing eCTD submissions reduces review times, leading to faster approvals
- Electronic storage/search functions result in faster navigation within and between submissions
- Going paperless saves on storage space and
- Improved ability to manage product lifecycle
- Cost reductions associated with all of the above
There are numerous benefts to creating and managing eCTD submissions:
- Filing eCTD submissions reduces review times, leading to faster approvals
- Electronic storage/search functions result in faster navigation within and between submissions
- Going paperless saves on storage space and reduces administrative burden
- Improved ability to manage product lifecycle
- Cost reductions associated with all of the above
We can support you with all of the eCTD formats there are, from EU to all over the globe:
Europe
- Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP), Clinical Trial Application (CTA), Originals, Variations, AtoQs, Renewals, ASMF eCTD Submissions, Medical Device Submissions
Swiss Medic – Switzerland
Initial submissions, Responses, Variations
North America
- Investigational New Drug (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Over the Counter (OTC), Drug Master Files (DMF Submissions), Structured Product Labeling (SPL) Submissions, supplemental new drug application (sNDA Submissions), Originals, Amendments, Annual report Submissions, Labeling Supplement Submissions, Periodic Adverse Drug Experience Report (PADERS), Briefng Book, eCTD baseline Submissions, Ad Promo Submissions, eCTD Submissions for lifecycle management (LCM)
Health Canada – Canada
- New Drug Submission (NDS), Supplement to a New Drug Submission (SNDS), Supplement to a New Drug Submission – Confrmatory (SNDS-C)
- Abbreviated New Drug Submission (ANDS)
- Supplement to Abbreviated New Drug Submission (SANDS)
Australia
- Market Authorization Application (MAA)
Asia
- Initials, Amendments
Middle East
- New Market Authorization (MA), Renewals of MA, Variation Type 1 and Type 2, Responses to Questions, Periodic Safety Update Report (PSUR) submissions
Ministry of Health (MOH) – Oman
- New MA, Renewals of MA, Variation Type 1 and Type 2, Responses to Questions, Periodic Safety Update Report (PSUR) submissions
Africa
Marti Farm will assist in:
- Supporting companies with regulatory compliance and periodic use of eCTD service
- Transitioning existing dossiers into eCTD format
- Secure and dependable infrastructure aimed to protect your intellectual property
- Support with new submissions
- eCTD support to consulting companies
format effectively and promptly in the EU
and globally, we invite you to
format effectively and promptly in the EU
and globally, we invite you to
Contact us
Headquarters
Lašćinska cesta 40
HR-10000 Zagreb
Croatia
Office
Planinska ulica 13/2
HR-10000 Zagreb
Croatia
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com
Pharmacovigilance
farmakovigilancija@martifarm.com
Tel: +385 1 5588 297
Legal info
Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121
OIB
Share capital
Authorized representative
29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
Bank account
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)
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