The use of CTD/eCTD templates is a proven efficiency in the authoring of eCTD documents, whether it is a paper or electronic submission. The use of the templates assures consistent formatting and prevents the previously-common situation where the publishing group was burdened with having to reformat all of the documents because the authors did not meet the publishing standards. This inefficiency can delay the submission timeline significantly, and this is something that can and should be prevented.
The eCTD templates can be purchased or created by the sponsor, and they must follow a fixed style guide with company-approved headers/footers and headings that match eCTD specifications. It is highly useful, even to the experienced submission author, to provide annotations in the templates (or accompanying the templates in a separate document) that specify the content required in each section of the eCTD. Some purchased eCTD templates do provide annotations that reflect ICH guidance and perhaps some additional information.
It is important to note that no generic set of eCTD templates can provide all of the important information that authors need to include in each section of the eCTD. This is because every submission is product-dependent and region-dependent. This is particularly true with CMC submissions. Annotations should be reviewed and approved by the CMC submission team and management to avoid endless-loop reviews of submission components later on.
It is recommended that, in addition to formatting requirements, template annotations address the following:
• Directions for granularity; ideally each template should be a granular section of the eCTD from the start.
• Product-specific information, addressing ICH guidance
• Regional-specific information, addressing regional agency guidance
• Agreements and commitments from agency meetings and previous filings
• Definitions of acronyms and abbreviations, for consistency throughout the submission
• Instructions to put hyperlinks in blue text, since authors are responsible for letting publishing know which section is to be cross-referenced
Sponsors often have separate templates for IND and NDA applications. It is possible to have a master set of eCTD templates that address what information must be added or expanded throughout development, from phase 1 to phase 2 to phase 3 to NDA/BLA. This generic set would be customized for each product and granularity for life cycle management at the time of submission planning.
The level of detail in Module 3 increases in most sections of the submission, from IND to NDA. For example, IND 3.2.S.2.2 Description of Manufacturing Process for a small molecule with a standard manufacturing process may include only a detailed flow chart. By phase 2 additional details would be provided, and by phase 3 the level of detail would be nearing that of the NDA.
CTD Quality Consulting would be happy to discuss your eCTD template needs with you, and assist you in customizing your annotations, to enhance the efficiency of your submission process.
- Dr. Michelle Herrera Foster, CTD Quality Consulting, michelle@ctdquality.com, 978-356-0872
Wednesday, December 30, 2009
CTD Mapping and the eCTD TOC
The first step in planning a CMC submission is to map the source documents to each section of the eCTD Module 3. This is done according to the ICH M4Q guidance, and, for U.S. submissions, FDA’s eCTD TOC (Table of Contents). It is recommended to do this process early on, as early as 12 months before the NDA filing, to make sure that all components are understood and assigned, and for ready gap analysis. Project management uses this eCTD TOC in the global project timeline and tracking tasks to support the CMC filing.
CMC submissions draw from many sources of information and data to produce eCTD submission documents:
• Development reports: characterization reports, formulation development, etc
• GMP Documents: specifications, procedures, validation reports, stability reports, etc.
• Databases: Batch analysis, stability, etc.
• Data sheets (LIMS): Chromatograms, spectra, etc.
• Documents from CMOs, suppliers, testing labs
An effective eCTD Map is a spreadsheet with the following columns :
1. eCTD section, according to the chosen granularity
2. Source documents needed to prepare the eCTD section other sections of the eCTD that are dependencies for this section
3. Who is responsible for each section
4. Key issues and action items, that are important for tracking by the CMC group and project management
5. Regional-specific issues, as relevant
6. Timing of key source documents and data (to be linked with the project management timeline)
7. Timing of draft 1, draft 2, final draft, final pdf, and eCTD QC
It is my experience that sponsors who start with this mapping process, bringing in the full CMC team early to make important decisions, will be at a distinct advantage in the overall planning and efficiency of submission preparation. Project management and upper management will be on board early to understand the overview of the components, who they are assigned to, and any key issues of content or timing.
CTD Quality Consulting would be happy to show you an example of a CTD map and provide you with a complimentary call to discuss and determine areas of improvement for your submission planning and preparation.
- Dr. Michelle Herrera Foster, CTD Quality Consulting, 978-356-0872
CMC submissions draw from many sources of information and data to produce eCTD submission documents:
• Development reports: characterization reports, formulation development, etc
• GMP Documents: specifications, procedures, validation reports, stability reports, etc.
• Databases: Batch analysis, stability, etc.
• Data sheets (LIMS): Chromatograms, spectra, etc.
• Documents from CMOs, suppliers, testing labs
An effective eCTD Map is a spreadsheet with the following columns :
1. eCTD section, according to the chosen granularity
2. Source documents needed to prepare the eCTD section other sections of the eCTD that are dependencies for this section
3. Who is responsible for each section
4. Key issues and action items, that are important for tracking by the CMC group and project management
5. Regional-specific issues, as relevant
6. Timing of key source documents and data (to be linked with the project management timeline)
7. Timing of draft 1, draft 2, final draft, final pdf, and eCTD QC
It is my experience that sponsors who start with this mapping process, bringing in the full CMC team early to make important decisions, will be at a distinct advantage in the overall planning and efficiency of submission preparation. Project management and upper management will be on board early to understand the overview of the components, who they are assigned to, and any key issues of content or timing.
CTD Quality Consulting would be happy to show you an example of a CTD map and provide you with a complimentary call to discuss and determine areas of improvement for your submission planning and preparation.
- Dr. Michelle Herrera Foster, CTD Quality Consulting, 978-356-0872
The CMC Submission Team
The eCTD submission team works most effectively with the contributions of functionally-managed sub-teams (CMC, Nonclinical, Clinical, Labeling, and Regulatory Affairs/Publishing) and the dotted-line reporting to upper management through the Project Management Team.
In order to promote efficiency and effectiveness in the planning, preparation, and review of CMC submission documents, the CMC submission team should include active and responsible representatives, as follows:
• Authors: Subject matter experts and technical leads, assigned to each CMC section
• CMC Reviewers, i.e. key decision makers
• Representative(s) from the Contract Manufacturing Organization (CMO) who provides source documentation, some authoring of CMC sections, and review
• Regional partners (Europe, Japan, etc) to address regional differences
• Publishing/Regulatory Operations
• Regulatory Affairs, responsible for regulatory strategy and review
In addition, word-processing and editing assistance can be given to authors who need it through the functional areas (ideally) or by the publishing group.
It is recommended that the CMC sub-team meet on a regular basis, meeting weekly in the months preceding the submission.
CTD Quality Consulting would be happy to provide a complimentary call to discuss your current process and determine possible training needs that would improve your efficiencies in drug development.
- Dr. Michelle Herrera Foster, Ph.D., CTD Quality Consulting, 978-356-0872
In order to promote efficiency and effectiveness in the planning, preparation, and review of CMC submission documents, the CMC submission team should include active and responsible representatives, as follows:
• Authors: Subject matter experts and technical leads, assigned to each CMC section
• CMC Reviewers, i.e. key decision makers
• Representative(s) from the Contract Manufacturing Organization (CMO) who provides source documentation, some authoring of CMC sections, and review
• Regional partners (Europe, Japan, etc) to address regional differences
• Publishing/Regulatory Operations
• Regulatory Affairs, responsible for regulatory strategy and review
In addition, word-processing and editing assistance can be given to authors who need it through the functional areas (ideally) or by the publishing group.
It is recommended that the CMC sub-team meet on a regular basis, meeting weekly in the months preceding the submission.
CTD Quality Consulting would be happy to provide a complimentary call to discuss your current process and determine possible training needs that would improve your efficiencies in drug development.
- Dr. Michelle Herrera Foster, Ph.D., CTD Quality Consulting, 978-356-0872
Efficient Creation of CMC Submission Documents
There is ample room for improving efficiency in the creation of CMC documents for submissions, and this need is magnified for the preparation of eCTD documents. This article will introduce the current challenges and suggest solutions for improving efficiencies, according to the following topics that will be addressed in separate articles in this blog:
1. CMC eCTD Challenges and Solutions
2. The CMC Submission Team – see separate article
3. Mapping and Planning – see separate article
4. Granularity and Life Cycle Management – see separate article
5. Annotated Templates – see separate article
6. Submission-Ready Documents – see separate article
7. The Module 2 Quality Overall Summary and Key Messages– article to be written
8. Document Management – article to be written
Note: Chemistry, Manufacturing, and Controls (CMC) Documents are written for various applications:
• Clinical Applications:
– IND – Investigational New Drug Application
– CTA – Clinical Trial Application (EU)
– IMPD – Investigational Medicinal Product Dossier (EU)
• Marketing Applications:
– NDA – New Drug Application
– BLA – Biologics License Application
– ANDA – Abbreviated New Drug Application
– MAA – Marketing Authorization Application
• Drug Master Files (DMF)
• Amendments, Responses to agency questions
• Post-Approval Supplements and Variations, Annual Reports
CMC eCTD Challenges and Solutions
Writing CMC documents in eCTD has created more challenges than in other areas of the eCTD. With eCTD submissions, ownership is pushed back to the functional areas who create the pdf documents. Authors who have traditionally written their documents using their technical expertise, have to shift to a new era where publishing standards must be taken into account. Authors not only must understand the regulatory guidance and regional differences, but also must be trained on the use of eCTD templates for an efficient publishing process. Many of these technical folks have not needed to be proficient in Microsoft Word, but now they are being asked to create hyperlinks and stick to the style guide.
Take this new challenge and multiply it by the number of authors that contribute to Module 3. The authors come from various functional areas and contract manufacturing organizations. There must be effective leadership of the CMC submission group to coordinate consistent messages, terminology, format, and content in the various sections of Module 3.
If that’s not enough challenge in an organization transitioning to eCTD, the CMC authors must also understand the concept of life cycle management in order to decide on the appropriate granularity of the documents in Module 3. In addition, the reviewability of the eCTD document is dependent on the accuracy and effectiveness of the hyperlinks and bookmarks.
From interviews with eCTD vendors and industry sponsors alike, Module 3 has been the greatest challenge in the transition to eCTD.
The key problem is:
The publishing group doesn’t understand the CMC content to make decisions about granularity, hyperlinks, and bookmarks.
The CMC group has not historically understood the publishing process to know why this information is important to publishing, and the publishing process has also been evolving with the eCTD transition.
The key solution is:
The publishing group, Regulatory Affairs, and the CMC group must work as a team to create eCTD documents as efficiently as possible.
Suggested processes such as CTD mapping, annotation of templates, and preparation of submission-ready documents (described below) will improve efficiency if the team supports the processes.
See separate articles on:
• The CMC Submission Team
• Mapping and Planning
• Granularity and Life Cycle Management - to be updated in the future with case studies
• Annotated Templates
• Submission-Ready Documents
• The Module 2 Quality Overall Summary and Key Messages
• Document Management
1. CMC eCTD Challenges and Solutions
2. The CMC Submission Team – see separate article
3. Mapping and Planning – see separate article
4. Granularity and Life Cycle Management – see separate article
5. Annotated Templates – see separate article
6. Submission-Ready Documents – see separate article
7. The Module 2 Quality Overall Summary and Key Messages– article to be written
8. Document Management – article to be written
Note: Chemistry, Manufacturing, and Controls (CMC) Documents are written for various applications:
• Clinical Applications:
– IND – Investigational New Drug Application
– CTA – Clinical Trial Application (EU)
– IMPD – Investigational Medicinal Product Dossier (EU)
• Marketing Applications:
– NDA – New Drug Application
– BLA – Biologics License Application
– ANDA – Abbreviated New Drug Application
– MAA – Marketing Authorization Application
• Drug Master Files (DMF)
• Amendments, Responses to agency questions
• Post-Approval Supplements and Variations, Annual Reports
CMC eCTD Challenges and Solutions
Writing CMC documents in eCTD has created more challenges than in other areas of the eCTD. With eCTD submissions, ownership is pushed back to the functional areas who create the pdf documents. Authors who have traditionally written their documents using their technical expertise, have to shift to a new era where publishing standards must be taken into account. Authors not only must understand the regulatory guidance and regional differences, but also must be trained on the use of eCTD templates for an efficient publishing process. Many of these technical folks have not needed to be proficient in Microsoft Word, but now they are being asked to create hyperlinks and stick to the style guide.
Take this new challenge and multiply it by the number of authors that contribute to Module 3. The authors come from various functional areas and contract manufacturing organizations. There must be effective leadership of the CMC submission group to coordinate consistent messages, terminology, format, and content in the various sections of Module 3.
If that’s not enough challenge in an organization transitioning to eCTD, the CMC authors must also understand the concept of life cycle management in order to decide on the appropriate granularity of the documents in Module 3. In addition, the reviewability of the eCTD document is dependent on the accuracy and effectiveness of the hyperlinks and bookmarks.
From interviews with eCTD vendors and industry sponsors alike, Module 3 has been the greatest challenge in the transition to eCTD.
The key problem is:
The publishing group doesn’t understand the CMC content to make decisions about granularity, hyperlinks, and bookmarks.
The CMC group has not historically understood the publishing process to know why this information is important to publishing, and the publishing process has also been evolving with the eCTD transition.
The key solution is:
The publishing group, Regulatory Affairs, and the CMC group must work as a team to create eCTD documents as efficiently as possible.
Suggested processes such as CTD mapping, annotation of templates, and preparation of submission-ready documents (described below) will improve efficiency if the team supports the processes.
See separate articles on:
• The CMC Submission Team
• Mapping and Planning
• Granularity and Life Cycle Management - to be updated in the future with case studies
• Annotated Templates
• Submission-Ready Documents
• The Module 2 Quality Overall Summary and Key Messages
• Document Management
Submission-Ready Documents
Imagine what it would be like to be nearing a marketing application in appreciation that most of the reports for the filing were nearly complete, having been preparing “submission-ready” throughout development. Sounds unreal? With some planning and training, this could be a reality for your products, at any stage of development. Preparation of submission-ready documents during preclinical and clinical development reduces preparation and review time, makes more efficient use of resources, and expedites and achieves shorter sustainable submission cycles, thereby reducing cost and stress to the organization.
Documents may be written in early development in an expandable/modular format that allows for submitting in the IND and then amending, modifying and replacement throughout development. As the product moves through the development stages, gaps are filled with new data and findings, to meet marketing application demands. Regional differences, e.g. differences between what is required for Europe and the U.S., may be addressed using a modular format, allowing different subsections for different regions. Information that does not need to be submitted to regulatory agencies, but must be kept on file for GMP documentation, can be placed in appendices. The report can be quickly customized prior to submission with the relevant information.
Challenges in CMC Documentation
Preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions faces unique challenges not usually found in nonclinical and clinical documentation. Regulatory guidance is readily available for clinical study reports, for example, but format/content guidance is not as complete for all types of CMC documents. Preparation of CMC documentation is done by multiple departments, e.g. Research and Development, Manufacturing, Validation, Quality Control, Stability, etc. within the company as well as contract manufacturing and testing labs. Unless authors are trained up front with agreed-upon templates, inconsistency of content and format between reports can create problems for the regulatory reviewer. Knowing this potential issue well, Regulatory Affairs often asks departments to rewrite reports for the submission.
CTD Quality Consulting has been working with clients in the IND stages to prepare reports in submission-ready format to avoid inefficiencies and delays in finalizing submission reports for the NDA or other marketing application. The following lists examples of reports for which training can be provided to prepare submission-ready documents:
o Characterization
o Formulation Development
o Manufacturing Development
o Method Validation
o Justification of Specifications
o Process Validation
o Stability
o Stress Studies
o Container-Closure Evaluation
Benefits of the CTD Format
The Common Technical Document (CTD) developed by the International Conference on Harmonization (ICH) is required in Europe, Japan, and Canada and “highly recommended” by FDA for marketing applications. The CTD format is required in Europe (according to IMPD guidance) and Canada for investigational applications; it is also accepted by FDA for investigational new drug applications (IND). The CTD format and content is also, of course, required for eCTD submissions. The eCTD format is required for electronic submissions in the U.S.
The advent of the CTD not only allows for global harmonization of marketing applications but also provides standards to prepare submission-ready documents in the IND phases. This standardization also benefits project management and information management and facilitates drug development planning and life cycle management. Each section of the CTD can be treated as a technical report that can be written early in development and updated as needed until it is finalized for the submission.
Preparing the CTD from IND to NDA
Module 3 of the CTD, the “Quality” or CMC section of the CTD, can be expanded from the IND to the NDA according to requirements for each phase of development. The following table illustrates key differences between the IND and NDA for Quality:
IND: Quality Overall Summary not required (except in Canada or for eCTD)
>NDA: Quality Overall Summary required (Module 2)
IND: Detailed manufacturing flow chart is sufficient for phase 1
>NDA: Complete manufacturing description, flow chart, manufacturing development history
IND: Viral safety evaluation required; other process validation not required
>NDA: Process validation summaries required for critical steps
IND: Assessment of critical method parameters
>NDA: Complete method validation reports
IND: Brief description of container closure
>NDA: Complete container closure evaluation
IND: Stability data support the duration of the clinical study
>NDA: Stability data support the proposed marketing shelf life, per ICH
IND: A.1 Facilities/Equipment not required
>NDA: A.1 Facilities/Equipment, A.2 Adventitious Agents for biologics
IND: The focus is on safety
>NDA: Complete details of CMC required
Writing Submission-Ready Documents
SRDs should be planned and written throughout development with four levels of reports in mind:
1) Reports that are submitted in full, with raw data and appendices, e.g. method validation report.
2) Summary reports without appendices, e.g. process development report.
3) High level summaries suitable for the Quality Overall Summary
4) Reports that are kept on file and not submitted
All reports required to meet GMP must of course be kept on file (level 4) even if they do not need to be submitted. For a level 1 report, the entire report would be submitted. For a level 2 report, the full report would be written with a body of the report that is in a summary format, such as a section of Module 3. The body of the report would include a summary of the protocol, key data tables and figures, summaries of methods, and conclusions. Raw data and other appendices could be removed prior to the submission. It is recommended that all reports have an up-front executive summary (level 3) that introduces key findings, resolution of issues, and recommendations. The content of these summaries would be integrated into the Quality Overall Summary in Module 2.
Reports written early in development may be written in submission-ready format and amended or updated throughout the course of development. One example of this is the method validation report, where methods are often refined or changed completely throughout development.
SRDs should be written in a modular format that has subsections for different regions, such as differing specifications in Europe and the U.S.. Just prior to submission, the subsections not relevant to that region are removed for the final report, with appropriate version control.
To make your reviewers’ job as easy as possible, it is highly recommended to keep consistency between reports of the same type in the submission, e.g. stability reports or method validation reports. Training of authors should also include consistency of terminology in all submission documents.
Electronic submission tools afford us some creative options in linking submissions to databases using XML. Ideally, the submission writer should not have write access to GMP data (such as release and stability data). Data tables within reports could be automatically populated from Quality-controlled databases using customized templates, with generation of graphs and statistical analysis
Regulatory Project Management
Planning a submission is a major project that requires skill, experience, and teamwork (see FAQ on the SMART Process at www.ctdquality.com). Using the CTD format to prepare submission-ready documents can greatly facilitate regulatory project management, by mapping data and reports to the CTD from the start. Project management software can be set up with sub-projects organized according to CTD subsections to track action items for each phase of development. This makes it easy to track and perform gap analysis.
CTD Quality Consulting wishes you the best in your submission preparation, and we would be happy to assist you with effective and efficient preparation of CMC submissions.
Do a piece at a time to have peace in time.
- Dr. Michelle Herrera Foster, CTD Quality Consulting
Documents may be written in early development in an expandable/modular format that allows for submitting in the IND and then amending, modifying and replacement throughout development. As the product moves through the development stages, gaps are filled with new data and findings, to meet marketing application demands. Regional differences, e.g. differences between what is required for Europe and the U.S., may be addressed using a modular format, allowing different subsections for different regions. Information that does not need to be submitted to regulatory agencies, but must be kept on file for GMP documentation, can be placed in appendices. The report can be quickly customized prior to submission with the relevant information.
Challenges in CMC Documentation
Preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions faces unique challenges not usually found in nonclinical and clinical documentation. Regulatory guidance is readily available for clinical study reports, for example, but format/content guidance is not as complete for all types of CMC documents. Preparation of CMC documentation is done by multiple departments, e.g. Research and Development, Manufacturing, Validation, Quality Control, Stability, etc. within the company as well as contract manufacturing and testing labs. Unless authors are trained up front with agreed-upon templates, inconsistency of content and format between reports can create problems for the regulatory reviewer. Knowing this potential issue well, Regulatory Affairs often asks departments to rewrite reports for the submission.
CTD Quality Consulting has been working with clients in the IND stages to prepare reports in submission-ready format to avoid inefficiencies and delays in finalizing submission reports for the NDA or other marketing application. The following lists examples of reports for which training can be provided to prepare submission-ready documents:
o Characterization
o Formulation Development
o Manufacturing Development
o Method Validation
o Justification of Specifications
o Process Validation
o Stability
o Stress Studies
o Container-Closure Evaluation
Benefits of the CTD Format
The Common Technical Document (CTD) developed by the International Conference on Harmonization (ICH) is required in Europe, Japan, and Canada and “highly recommended” by FDA for marketing applications. The CTD format is required in Europe (according to IMPD guidance) and Canada for investigational applications; it is also accepted by FDA for investigational new drug applications (IND). The CTD format and content is also, of course, required for eCTD submissions. The eCTD format is required for electronic submissions in the U.S.
The advent of the CTD not only allows for global harmonization of marketing applications but also provides standards to prepare submission-ready documents in the IND phases. This standardization also benefits project management and information management and facilitates drug development planning and life cycle management. Each section of the CTD can be treated as a technical report that can be written early in development and updated as needed until it is finalized for the submission.
Preparing the CTD from IND to NDA
Module 3 of the CTD, the “Quality” or CMC section of the CTD, can be expanded from the IND to the NDA according to requirements for each phase of development. The following table illustrates key differences between the IND and NDA for Quality:
IND: Quality Overall Summary not required (except in Canada or for eCTD)
>NDA: Quality Overall Summary required (Module 2)
IND: Detailed manufacturing flow chart is sufficient for phase 1
>NDA: Complete manufacturing description, flow chart, manufacturing development history
IND: Viral safety evaluation required; other process validation not required
>NDA: Process validation summaries required for critical steps
IND: Assessment of critical method parameters
>NDA: Complete method validation reports
IND: Brief description of container closure
>NDA: Complete container closure evaluation
IND: Stability data support the duration of the clinical study
>NDA: Stability data support the proposed marketing shelf life, per ICH
IND: A.1 Facilities/Equipment not required
>NDA: A.1 Facilities/Equipment, A.2 Adventitious Agents for biologics
IND: The focus is on safety
>NDA: Complete details of CMC required
Writing Submission-Ready Documents
SRDs should be planned and written throughout development with four levels of reports in mind:
1) Reports that are submitted in full, with raw data and appendices, e.g. method validation report.
2) Summary reports without appendices, e.g. process development report.
3) High level summaries suitable for the Quality Overall Summary
4) Reports that are kept on file and not submitted
All reports required to meet GMP must of course be kept on file (level 4) even if they do not need to be submitted. For a level 1 report, the entire report would be submitted. For a level 2 report, the full report would be written with a body of the report that is in a summary format, such as a section of Module 3. The body of the report would include a summary of the protocol, key data tables and figures, summaries of methods, and conclusions. Raw data and other appendices could be removed prior to the submission. It is recommended that all reports have an up-front executive summary (level 3) that introduces key findings, resolution of issues, and recommendations. The content of these summaries would be integrated into the Quality Overall Summary in Module 2.
Reports written early in development may be written in submission-ready format and amended or updated throughout the course of development. One example of this is the method validation report, where methods are often refined or changed completely throughout development.
SRDs should be written in a modular format that has subsections for different regions, such as differing specifications in Europe and the U.S.. Just prior to submission, the subsections not relevant to that region are removed for the final report, with appropriate version control.
To make your reviewers’ job as easy as possible, it is highly recommended to keep consistency between reports of the same type in the submission, e.g. stability reports or method validation reports. Training of authors should also include consistency of terminology in all submission documents.
Electronic submission tools afford us some creative options in linking submissions to databases using XML. Ideally, the submission writer should not have write access to GMP data (such as release and stability data). Data tables within reports could be automatically populated from Quality-controlled databases using customized templates, with generation of graphs and statistical analysis
Regulatory Project Management
Planning a submission is a major project that requires skill, experience, and teamwork (see FAQ on the SMART Process at www.ctdquality.com). Using the CTD format to prepare submission-ready documents can greatly facilitate regulatory project management, by mapping data and reports to the CTD from the start. Project management software can be set up with sub-projects organized according to CTD subsections to track action items for each phase of development. This makes it easy to track and perform gap analysis.
CTD Quality Consulting wishes you the best in your submission preparation, and we would be happy to assist you with effective and efficient preparation of CMC submissions.
Do a piece at a time to have peace in time.
- Dr. Michelle Herrera Foster, CTD Quality Consulting
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