ECTD Pharma | Global ectd submission service

Green Gradient Technology ProfessionalBu

Delivering strategic regulatory guidance, technical readiness, and flawless submissions across the product lifecycle

At ECTD Pharma, we go beyond technical publishing — we provide senior regulatory leadership and hands-on support across the full regulatory process, from gap analysis and strategic planning through document readiness, eCTD publishing, and lifecycle submissions

Comprehensive Regulatory Operations
and Publishing Services

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Full Regulatory

Affairs Support

Submission life cycle management

eCTD Publishing Services

Regulatory Document Preparation

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

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ECTD Pharma's Offerings

Regulatory Gap Analysis & Readiness Assessment — Evaluate readiness and create a tailored plan for EU and global submissions

Strategic Regulatory Planning — Define optimal submission pathways and timelines aligned with regulatory requirements

Regulatory Coaching & Team Support — Work alongside your regulatory team to build internal capability while delivering expert guidance

Dossier Structuring & Submission Readiness — Ensure all modules, metadata, and documents are prepared for technical compliance and authority review

eCTD Publishing & Validation — Compile, validate, and submit regulatory dossiers using state-of-the-art publishing systems

Lifecycle Management & Authority Interaction — Manage responses, variations, renewals, and ongoing regulatory communications

"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