Planning, managing, tracking, and ensuring on-time production and delivery of submissions
Provide technical advice to maximize efficiency and quality
Advise on technical and associated strategic submission elements such as Lifecycle implications, eCTD validation and ensuring a well formed eCTD
Submission Intelligence
Up to date with Submission formats and eCTD specification updates
Advising on new submission formats, the structure and ensuring a well formed eCTD
eCTD Implementation in new countries accepting eCTD
PREPARE
MS Word Formatting
Ensuring consistency throughout MS Word documents
MS Word formatting for PDF Conversion
Adding Internal hyperlinks, heading styles and Table of Contents
All MS Word technical issues resolved
MS Word Training
Offering onsite and virtual MS Word Training to unlock the power of completing simple tasks better and faster. Learn how to customise formatting of styles, integrate tables, add cross references and table of contents and much more. AEH offers a wide variety of training with word to fit your businesses needs and requirements.
MS Word Template Creation
Creating Quick Reference Guides for MS Word for use internally
Creating templates for authors for use internally within your company, saving time and ensuring consistency
Submission Ready PDFs and Report Publishing
Submission Ready PDFs per validation criteria and agency requirements
Hyperlinking and bookmarking per agency requirements
Report publishing including CSRs, RMPs, Safety Reports, IMPDs
PUBLISH
Submission Publishing
eCTD Submissions
Industry best submission practises
Expertise in submitting eCTDs all over the world
Lifecycle management and best practises for all eCTD submission types
eCTD Validation
EMA Policy 0070 Submissions
New submission type with the EMA
Best practise on how to submit per specific guidance
NeeS
Some countries still ask for submissions in NeeS format, we can help to accommodate this and ensure that the submission meets the requirements
NeeS validation
eSubmissions
Covering all submission types that do not fall under eCTD and NeeS format
PIPs: Compilation of the package ready for submission
Briefing Books: Compilation of the package ready for submission
eCTD Baseline Conversions
Industry best practises
Expertise in submitting baselines all over the world
eCTD validation
Importing and Cloning of Existing eCTD Applications
CTA/IND Submissions
Covering all agency formats as per the guidance
Paper, electronic and eCTD submissions
SUBMIT
Submitting to an agency
Submitting your submissions direct to the agency
"AEH has been just fantastic to work with and did a great job through all of the difficult QC especially with the changes and communicating every detail back and forth."
