• New Course: Easing the Transition to CTD/eCTD for INDs/NDAs Details Here
• Preparing CMC Submissions in CTD Format from IND to NDA Details Here
• The CTD/eCTD: Building the Marketing Application Throughout Clinical Development, offered through the Center for Professional Innovation and Education. Details Here
• cGLP/ cGMP-A Basic Primer
• CTD Quality Submission Preparation
• Customized courses are available upon request

Preparing CMC Submissions in CTD Format from IND to NDA

Would you like to reduce cycle times and costs for Chemistry, Manufacturing, and Controls (CMC) submissions using simple processes that can be implemented easily and quickly? CTD Quality Consulting can help you build more efficiency into your processes for preparing CMC strategy and submissions. See the attached flyer for an updated course offering entitled Preparing CMC Submissions in CTD Format from IND to NDA delivered on-site to your organization.

This course not only provides training in the content and format of Chemistry, Manufacturing, and Controls (CMC) submissions, but also presents proven processes for expediting and achieving shorter sustainable submission cycles, with lower cost, less preparation and review time, and more efficient use of resources, with less stress to the organization. Customization of training for your particular product and technical groups can also be pre-arranged to enhance learning for your on-site course. With a confidentiality agreement in place, a customized course allows for open discussions using actual data, issues, and solutions for a particular product. This also provides a unique opportunity to bring the project team together to discuss strategy in the context of the training. We can co-design the right course for your organization

Training Case Studies

Training on CTD format/content and CMC requirements for regulatory strategy benefits sponsors at all stages of development:

1. Phase 1-3: Planning CMC strategy, pre-IND meeting(s), and INDs in the CTD format aligns information for preparation of submission-ready documents for NDA/BLA submissions. Gap analysis is done more effectively, with savings of time, resources, and money in regulatory documentation.
2. NDA/BLA: The submission team is best served with early training for authoring and reviewing of CTD sections. Training at this point results in efficient preparation of the marketing application and anticipation of potential agency questions. In addition, creating the pre-NDA meeting document in CTD format helps sponsors strategize more effectively for the NDA.
3. Post-Marketing: Life cycle management is eased by the CTD format, allowing smooth preparation of post-marketing supplements and supporting variations in all markets.

The following are examples of how training has recently benefited CTD Quality Consulting’s clients at different phases of development. CTD Quality Consulting provides various ways in which clients can get their training needs met within their resource and budget allocations:

Case 1 – NDA preparation starting in Phase 2-3: It has been a pleasure working with one of our Boston area clients since 2004 when they were in phase 2-3. At that time, we provided training on CTD Module 3, performed gap analysis for the NDA, set up submission-ready documentation formats for documents such as method validation reports, and worked with their vendors to provide Drug Master Files in the CTD format for their two novel excipients. In 2006, the client was enjoying the benefits of starting early to prepare the CTD sections of an NDA; authors had prepared most of the sections in advance, and reports such as formulation and process development documents were in place to be summarized for the NDA. Writing an NDA is a lot of work, and starting off right avoids a lot of re-writing throughout development that saves substantial time and cost in preparation of the final marketing application.

Case 2 – BLA Preparation from CTD templates: CTD Quality Consulting prepared customized detailed content templates for each section of CTD Module 3 for a Boston-area biotechnology client. Every product is so different, and it was important to work with the technical leads on each section to make sure we were capturing complete technical as well as regulatory information. Regulatory ensured that all correspondence with the agency was addressed and all FDA commitments accounted for.

Case 3 – Preparation of Pre-NDA meeting and First-Time NDA: One of our New York area clients went through a steep learning curve to prepare their first NDA with limited resources and they had become dependent on their contract manufacturers for documentation that wasn’t in submission-ready format. CTD Quality Consulting worked closely with them to prepare a pre-NDA meeting package based on information collected during preparation of the first drafts of the Drug Substance and Drug Product sections. Working in the CTD format from the beginning helped align authors and management to agree on the FDA meeting strategy and to uncover gaps in information needed from their contract manufacturers well in advance. This helped prepare and review the NDA sections more efficiently; CTD Quality Consulting provided writing resources to supplement their available resources and reviewed the entire application for completeness and consistency.

Case 4 – Preparation of NDA for Combination Product: One of our west-coast clients is a large device company that was to submit its first PMA for a drug-device product. The steep learning curve was challenged by the cultural transition from a device to a drug company philosophy, which involved learning GMPs as well as drug regulatory requirements. The client was very pleased with the training we provided to the authors, which followed a model path. We started with a 1-day course on CTD Module 3 presented to the regulatory group to get them primed for preparation of CTD templates. The CTD templates were customized for their product and the templates were subsequently refined with input from regulatory and technical leads. The authors received training on the customized templates, and then prepared drafts which we reviewed and edited for completeness and consistency.

Case 5 – Pre-IND Meeting and IMPD/IND Preparation: Another west-coast client contracted CTD Quality Consulting to prepare a pre-IND meeting package. With the strategy we set up in the CTD-formatted package, preparation of CTD templates were easily prepared for authors to plan their IND. Their clinical strategy shifted to performing clinical trials in Europe first, and the IND templates are applied easily to the preparation of IMPD in CTD format.

Case 6 – ANDAs and 505b(2) NDAs: We provided a 2-day training to another client on the west coast who partners with drug companies to re-formulate and submit 505 b(2) NDAs and ANDAs through their company or their partners. They were very pleased to receive the knowledge in the training to prepare submission-ready documents, thereby providing added value to services to their partners, and to make their own IND and NDA submission processes more efficient.

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