It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China



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eCTD:Highlights and Updates

03 Jun 2017

he electronic common technical document or eCTD is an interface designed for the pharmaceutical industry to transfer regulatory information. This module-based regulatory application format was developed by the International Conference on Harmonization (ICH). In 2008, the United States Food and Drug Administration (FDA) made the eCTD format mandatory for all electronic submissions.

eCTD format is now widely used in the United States, Japan, the European Union and Canada.On May 5, 2015, the U.S. Food & Drug Administration published a final, binding guidance document requiring certain submissions in electronic (eCTD) format within 24 months. The projected date for mandatory electronic submissions is May 5, 2017 for New Drug Applications (NDAs), Biologic License Applications (BLAs), Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs). Till date, more than 600,000 eCTD sequences have been submitted to the FDA.

Lambda has expertise in preparing the dossiers that comply with the eCTD specifications. Dossiers go through a well-defined and streamlined work flow so that the final document is of utmost quality before submission to the regulatory bodies.

There are total 5 modules that a pharmaceutical company has to submit to the FDA.

  • Module 1: Regional administrative information
  • Module 2: Quality overall summary (includes Non-clinical overview, clinical overview, Non-clinical summary, Clinical summary)
  • Module 3: Quality
  • Module 4: Non-clinical study reports
  • Module 5: Clinical study reports

Lambda has extensive experience in developing Module 5. We also help in preparing Module 2.4 (i.e. Non Clinical Overview), Module 2.5 (Clinical Overview) & Module 2.7 (Clinical Summary).

USFDA has released a guidance on the PDF specifications, Version 4.0, in September 2014. Reason for the revision is to align with the ICH recommendation on PDF. Major changes in Version 4.0 are with regards to the font type, font size, document navigation and maximum allowable PDF file size.


Some of the points that are taken care by Lambda (but not limited to) while dossier preparations are:


  • PDF version should be 1.4
  • All the documents should be text searchable.
  • No security settings or password protection.
  • Fully embed all non-standard fonts. Use font sizes ranging from 9 to 12 point. Times New Roman 12-point font is recommended for narrative text. Ten point fonts are recommended for footnotes.
  • Page orientation for proper viewing and printing within the documents.
  • Margins should be 0.75 on left side and at least 0.375 on the other three sidesUse of image should be avoided. Scanning should be done with minimum 300 dpi.
  • Fast web view should be selected to reduce file sizes and file opening times.
  • TOC should be prepared in case of files having 5 or more pages. Bookmarks and TOC should go together.
  • When creating bookmarks and hyperlinks, the magnification setting must be set to “Inherit Zoom” so the destination page displays at the same magnification level used in the primary document.
  • Initial view should be “Bookmarks Panel and Page”, and Page Layout & Magnification should be set to “Default.”
  • Naming of PDF files should be in the lower case, avoiding special characters except hyphen and underscore.
  • Maximum files size allowed by FDA is 100 MB, if there is any file which is exceeding the limit it needs to be split with clear TOC, Bookmark & Hyperlink

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