Structure-Data File Format (SD)
Since 1st October 2022, applicants may now submit chemical structures as a single Structure-Data File format.
Are you holding a dossier in US? If the answer is YES, this brochure may be of your interest!
Asphalion has its own regulatory operations team. Many pharmaceutical companies across the globe rely their publishing activities on our team, which offers multidisciplinary skills and services and embrace a different bunch of services like publishing activities in different formats.
Our experienced regulatory specialists work with the latest software using self-developed project management tools to guarantee compliance with critical submission timelines.
Many of our regulatory experts have decades of experience providing support for all types of regulatory procedures and types of dossiers. Our team collaborates regularly with Health Authorities, industry experts and EMA (European Medicines Agency) SMEs (Subject Matter Experts), making Asphalion your ideal partner for the most challenging regulatory submissions.
Asphalion has its own regulatory operations team. Many pharmaceutical companies across the globe rely their publishing activities on our team, which offers multidisciplinary skills and services and embrace a different bunch of services like publishing activities in different formats.
Our experienced regulatory specialists work with the latest software using self-developed project management tools to guarantee compliance with critical submission timelines.
Many of our regulatory experts have decades of experience providing support for all types of regulatory procedures and types of dossiers. Our team collaborates regularly with Health Authorities, industry experts and EMA (European Medicines Agency) SMEs (Subject Matter Experts), making Asphalion your ideal partner for the most challenging regulatory submissions.
Regulatory Operations: eCTD Publishing and eSubmissions Solutions
Our services:
Boost your company health authorities approvals with the help of Asphalion’s Regulatory operations team. This is a comprehensive list of the publishing & submission related services that are most frequently demanded by our customers. If you have any other particular need, just let us know and we will manage it for you.
Moreover, Asphalion has a solid partnership with Extedo of more than 10 years, using their tools for publishing activities (e.g., eCTD Manager®, EURS Validator®) and providing customer support on their behalf for their regional clients.
Publish submission-ready documentation more quickly with Asphalion’s expertise. This is a comprehensive list of formatting related services that are most frequently demanded by our customers. If you have any other particular need, just let us know and we will manage it for you.
Implement regulatory affairs software right from the beginning wit our experise. This is a comprehensive list of software related services that are most frequently demanded by our customers. If you have any other particular need, just let us know and we will manage it for you.
We offer training courses on eSubmissions and Publishing with Extedo’s tools eCTDManager, EURSValidator and eSUBManager.
The content and duration are fully adaptable to the client’s needs and to the users’ knowledge level.
The training is delivered by experts in the area and includes the deliverables of the training material (i.e., manuals, guidelines, presentations, etc.) and the issuance of a training certificate.
The training methodology is mainly online, although it can also be carried out in person, as per your request. Training sessions are interactive and can be delivered both in Spanish and English, and the number of online attendees is unlimited. Additionally, a training server can be enabled for the attendees to carry out real practical cases.
This is a comprehensive list of the most demanded training topics:
Increase your productivity and reduce cost with the expertise of Asphalion’s Regulatory Operations consulting team.
Customize your Regulatory Intelligence (RI) database by subscribing to Asphalion’s Regulatory Operations newsletter, helping you to avoid resource-intensive process of gathering regulatory information:
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Why Asphalion?
At Asphalion, we have been at the forefront of electronic submission of regulatory information since the introduction of eCTD.
As a result of our flexible support and dedicated project management, we can produce high quality submissions within critical timelines.
We have been offering eCTD services since 2008 and, nowadays, we manage over 1,500 eCTD sequences per year.
Our ISO 9001 certification ensures traceability and secured storing.
Related Resources
Since 1st October 2022, applicants may now submit chemical structures as a single Structure-Data File format.
Are you holding a dossier in US? If the answer is YES, this brochure may be of your interest!
Asphalion ensures that eCTD submission will always follow the most updated Module 1 GCC specifications and validation rules.
IND preparation and submission business case: A small European biotech company focused on drug discovery and development interested in engaging with the FDA.
In this business case about an Asphalion eSubmission NDA, a Swiss Pharmaceutical company needed assistance with an initial complete NDA application, including datasets and SPL.
Asphalion contributions to the fight against COVID-19
A guide to have an overview of regional submissions requirements
(CTR) No 536/2014
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other regions.
Scientific & Regulatory Affairs Support during development of ATMPs & Biologics
Beginning 15th September 2021
, FDA will enforce the
TechnicalRejection Criteria (TRC)
for Study Data by
CDER
and
CBER
.
We are providing specific training for pharma and biotech companies inorder to guide them through the correct implementation of the new system.
This white paper examines the business drivers behind this shift and three factors that are critical to maximizing thebenefits of a unified RIM solution.
A case study about Marketing Authorization Expansion in Europe. A small European
Pharmaceutical company with
local activity in its country, with a
growth strategy aiming to
expand to international
markets but lacking experience
and capability in managing
complex EU procedures.
The EU Regulatory Environment of Medical Device Software Development
The SDF is an extensible, portable text file encoding computer-readable chemical structures linked to associated data fields. Is also commonly called an SD File or an .sdf. On October 1st,
Are you planning to send a submission to the FDA? Will this submission contain study data? If the answer to these 2 questions has been yes, this brochure may be
Have a look at this infographic that Extedo® and Asphalion prepared with the summary updates in terms of publishing and eSubmission at a regional level. On this occasion, we are
Services
Memberships & Partnerships
Quality Management System
© Asphalion
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
