Comprehensive solutions for your
Regulatory needs
Here at ECTD Pharma all submissions are built and managed using our in-house publishing platform, powered by one of the world’s leading regulatory software providers. We offer full lifecycle management, ensuring your dossiers are always up to date, submission-ready, and securely stored for future use. From initial compilation to long-term maintenance, we take the stress out of your regulatory journey — so you can focus on bringing your product to market
ECTD Pharma's 6 Step
Publishing Process
Pharmaceutical Product Testing​
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We provide comprehensive analytical testing and regulatory support to pharmaceutical and life science organisations. Our services are tailored to help you bring your product to market efficiently while ensuring full compliance with UK, EU, and global regulatory standards. Our pharmaceutical testing capabilities are built around three core areas:
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QC release testing
Analytical Method Development
Compliance
We provide Qualified Person (QP) oversight and batch certification for the UK and EU, full support with MIA applications, and strategic regulatory guidance to accelerate product development and launch. We also offer comprehensive GMP-compliant analytical testing — including method development, validation, stability studies, and raw material and finished product analysis. These enhanced services enable us to support your product journey from initial submission all the way to market release with precision and compliance at every step.
Why Choose ECTD Pharma?
At ECTD Pharma, we combine regulatory expertise with advanced technology to deliver fast, accurate, and compliant submissions. Our goal is to simplify the regulatory process, minimize risks, and help you achieve faster product approvals.Contact us today to streamline your regulatory submissions and ensure global compliance.
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FDA eCTD Publishing Services -
Expert preparation, compilation, and submission of electronic Common Technical Document (eCTD) submissions to meet FDA regulatory requirements
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EMA eCTD Publishing Services -
Seamless eCTD publishing for the European Medicines Agency (EMA), ensuring compliance with EU regulatory standards
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Rest of World (ROW) & NeeS Publishing -
Comprehensive submission support for global markets, including Non-eCTD electronic Submissions (NeeS), tailored to specific regional requirements.
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Regulatory Document Preparation -
Professional preparation, formatting, and quality checks of regulatory documents to ensure submission readiness and compliance.
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Lifecycle Management Submissions -
Ongoing support for post-approval regulatory activities, including variations, renewals, amendments, and regulatory updates.
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Investigator-Initiated Submissions -
Assistance with regulatory submissions for investigator-led clinical trials, ensuring compliance with international guidelines
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Specialized Regulatory Applications
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Investigational New Drug (IND) Applications -
Full support for preparing and submitting IND applications to initiate clinical trials in the United States.
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New Drug Application (NDA) Submissions -
Comprehensive NDA submission services to secure product approvals from regulatory authorities.
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Abbreviated New Drug Application (ANDA) Submissions -
Efficient preparation and submission of ANDAs for generic drug approvals, ensuring timely market entry.
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Marketing Authorization Application (MAA) Submissions -
Expert MAA submission services for the European Union and other global markets, supporting both centralized and decentralized procedures.
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Biologics License Application (BLA) Submissions -
Specialized regulatory support for preparing and submitting BLAs for biologic product approvals.
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Clinical Trial Application (CTA) Submissions -
Global CTA submission services to support the initiation and management of clinical trials in compliance with regional regulations.
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Drug Master File (DMF) Submissions -
Preparation, submission, and maintenance of DMFs to ensure compliance with regulatory requirements for drug substances, excipients, and packaging materials.​​​​​​
Contact
Get in touch to learn more
