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Services Overview:

  • FDA publishing

  • EMA publishing

  • ROW and Nees publishing

  • Document preparation

  • Investigator Submissions 

  • Investigational New Drug (IND)

  • New Drug Application (NDA)

  • Abbreviated New Drug Application (ANDA)

  • Marketing Authorization Application (MAA)

  • Biologics License Application (BLA)

  • Clinical Trial Application (CTA)

  • Drug Master File (DMF)

  • Variation Submissions (Type 1A, 1AIN, 1B, 2)

  • Line Extensions 

  • New Indications 

 

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Book an free initial Consultation

We’re here to handle all your publishing needs with ease. Our expertise and processes ensure seamless and efficient submissions every time.

Find Us

Tel:  +447506975972  &  +447734219260

info@ectdpharma.com

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Regulatory Submission Services | eCTD Publishing Experts – eCTD Pharma
At eCTD Pharma, we deliver industry-leading regulatory submission services tailored for the pharmaceutical, biotech, and healthcare sectors. Our expertise in eCTD publishing, regulatory gap analysis, and legacy submission conversions ensures your submissions are 100% compliant with EMA, FDA, and global health authority standards. Using advanced Freyr software, we provide fast, accurate, and secure electronic submissions, reducing approval timelines and minimizing compliance risks. Whether you need end-to-end eCTD submission support, lifecycle management, or expert consultancy, eCTD Pharma is your trusted partner. Maximize compliance. Minimize delays. Accelerate approvals. Contact eCTD Pharma today to streamline your regulatory process.

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