ECTD Pharma | Global ectd submission service

Green Gradient Technology ProfessionalBu

Your trusted partner for seamless regulatory submissions

Helping global pharmaceutical, Medical Device and Life Science companies navigate the complex process of preparing and submitting regulatory dossiers to health authorities in the electronic format required for marketing authorization in all regions

Comprehensive Regulatory Operations
and Publishing Services

Submission life cycle management

eCTD Publishing Services

Regulatory Document Preparation

OUR SERVICES

Trusted and experienced consultants across the industry

30+

Years of ECTD
management experience

5000+

Submissions completed

100%

Submission acceptance rate

Contact Us

We’re here to handle all your regulatory needs with ease. Our expertise and processes ensure seamless and efficient submissions every time

Book

ECTD Pharma's 6 Step
Publishing Process

Step 1 - Consultation

Here we discuss the process and go through all the questions you have to ensure a seamless experience

Step 2 -

Document Prep

We review all your documents to ensure these are in line with eCTD Requirements

Step 3 - Compilation

Here we convert and organise all the documents in eCTD format along with hyperlinking and bookmarking

Step 4 -

Publishing and Validation

All documents are published and validated through our in house eCTD software. Followed by rigerious Quality Checks

Step 5 -

Submit to Authorities

ECTD Pharma can submit the Dossier if the clients prefers. We then provide you with the receipts and approval emails

Step 6 -

Lifecycle Management

We offer this service to all clients. We store the submission on our publishing system for future updates you may need, saving you money going forward

"ECTD Pharma has been an invaluable partner for our regulatory submissions. Their team provided expert eCTD document preparation and ensured our FDA and EMA submissions were fully compliant. From IND and NDA filings to clinical trial applications, they managed the entire process with precision and efficiency. Their in-house eCTD publishing software streamlined everything, and their ongoing support throughout the eCTD life cycle has been a huge asset. Highly recommend their services!"

Simon - Project Manager