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You will get an eCTD package publishing for submission to Health Authorities

Mikhail T.
Mikhail T.
Rising Talent
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Let a pro handle the details

Buy Legal Consulting services from Mikhail, priced and ready to go.

You will get an eCTD package publishing for submission to Health Authorities

Mikhail T.
Mikhail T.
Rising Talent

Select service tier

S

eCTD package for submission to Authorities (1 - 20 documents)

  • Delivery Time 3 days
  • Number of Revisions 1

3 days delivery — Sep 14, 2024
Revisions may occur after this date.
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Upwork Payment Protection
Fund the project upfront. Mikhail gets paid once you are satisfied with the work.
Preview image

Let a pro handle the details

Buy Legal Consulting services from Mikhail, priced and ready to go.

Project details

I will provide you with the following:
eCTD package ready for submission to Authorities;
Which countries?
EU
CH
GCC
For other countries, please contact me first.

Which documents are to be provided?
Documents of Module 1 - 5 of the dossier that should be published, in Word or pdf format.
Necessary information about submission (country, MA number, name of the company, product name, API, etc)
If your dossier already has the eCTD lifecycle: Submission instruction or the previous eCTD lifecycle or all XML files from the previous eCTD lifecycle.
I am NOT performing delivery of the package to Authorities.
For any consultation concerning regulatory affairs / CMC / regulatory operations topics feel free to contact me.
Field of Law
Health & Medical
Target Country
Worldwide
Language
English
Service Type
Legal Assistance, Legal Writing, Documentation Review, Regulation & Compliance
What's included
Service Tiers Starter
$150
Standard
$480
Advanced
$960
Delivery Time 3 days 5 days 7 days
Number of Revisions
111
Optional add-ons You can add these on the next page.
Fast Delivery
+$120 - $640
Mikhail T.

About Mikhail

Mikhail T.
Regulatory Affairs Manager | CMC | Regulatory operations
Hinrichshagen, Germany - 10:44 pm local time
As an experienced Regulatory Affairs Manager with a background in Pharmaceutical Biotechnology, I bring over 5 years of expertise in global regulatory affairs, specializing in small molecule medical products. Throughout my career, I have supported the lifecycle of the eCTD dossier for a wide variety of projects.

Steps for completing your project

After purchasing the project, send requirements so Mikhail can start the project.

Delivery time starts when Mikhail receives requirements from you.

Mikhail works on your project following the steps below.

Revisions may occur after the delivery date.

Receive documents from client

Compile documents in eCTD package

Review the work, release payment, and leave feedback to Mikhail.