Comprehensive Regulatory Operations
and Publishing Services
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.
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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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.
ECTD Pharma is your trusted partner for accurate, strategic, and stress-free regulatory submissions.
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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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Investigator Submissions
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Investigational New Drug (IND)
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New Drug Application (NDA)
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Abbreviated New Drug Application (ANDA)
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Marketing Authorization Application (MAA)
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Biologics License Application (BLA)
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Clinical Trial Application (CTA)
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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
