Our Offerings
Vendor Partnership Model
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We act as an external regulatory publishing partner, delivering end-to-end eCTD submissions and lifecycle management
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This model provides:Fixed-scope, clearly priced submissions
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Senior-led delivery and full accountability
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Scalable support across multiple products
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Long-term hosting and submission managemen
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This approach is ideal when work needs to be delivered efficiently without increasing internal headcount.
Embedded Consultant Model
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We provide senior regulatory operations specialists who embed directly into your team as consultants
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Immediate access to deep technical expertise
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Experiecned in integration with internal systems and processes
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Support high workload
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Knowledge transfer and continuity within your organisation
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This approach works best when internal teams need hands-on, specialist support without long-term hiring commitments.
Why Choose ECTD Pharma?
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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.
​Specialized Regulatory Applications
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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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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
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