Your trusted partner for seamless regulatory submissions
Comprehensive Regulatory Operations
and Publishing Services
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FDA publishing
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EMA publishing
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ROW and Nees publishing
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Document preparation
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Life cycle submissions
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Biologics License Application (BLA)
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Marketing Authorization Application (MAA)
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New Drug Application (NDA)
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Clinical Trial Application (CTA)
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Investigator Submissions
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Investigational New Drug (IND)
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Abbreviated New Drug Application (ANDA)
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Drug Master File (DMF)
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Variation Submissions (Type 1A, 1AIN, 1B, 2)
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Line Extensions
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New Indications
What Makes Us Different:
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Hands-on expertise - Work directly with a seasoned regulatory publisher, not a project coordinator.
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Fast, flexible turnaround - Agile service for startups, biotech, and pharma teams with tight deadlines.
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30+ years combined eCTD management experience, 5000+ submissions completed
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Flexible, hands-on consultancy with fast turnaround for startups and global teams.
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Gap analysis & conversion pros - We identify issues others miss and ensure your submissions are submission-ready.
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Regulatory peace of mind - Your dossiers are always audit-ready, fully validated, and agency-compliant.
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End-to-end submission support across MHRA, EMA, FDA.
ECTD Pharma is your trusted partner for accurate, strategic, and stress-free regulatory submissions.
Why choose us?
Big CRO expertise. Boutique consultancy care. At eCTD Pharma, we provide expert regulatory publishing services with the precision and reliability you'd expect from a large CRO — but with the flexibility, speed, and personal attention only a specialist consultancy can offer. Whether you're preparing your first eCTD submission or converting legacy dossiers, we help you stay compliant, avoid delays, and accelerate approvals across MHRA, EMA, and FDA pathways.
ECTD Pharma is a UK & US regulatory publishing consultancy providing expert eCTD submissions, gap analysis, lifecycle management, and legacy dossier conversions for pharmaceutical, biotech, and medical device companies. Using industry leading software, we ensure submissions are audit-ready, agency-compliant, and efficiently processed.
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30+ years combined eCTD management experience, 5000+ submissions completed.
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End-to-end submission support across MHRA, EMA, FDA.
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Flexible, hands-on consultancy with fast turnaround for startups and global teams.