TEMPLATES

A solid foundation.

Smart organizations look for strategies to streamline the process of writing and submitting documents. Designed by a team of medical writers and editors, Acumen’s suite of eCTD templates are enriched with tips obtained from years of submission writing.

Our templates comply with the most up-to-date regulatory standards (FDA, EMA, PFDA, and ICH) based on the internationally accepted Common Technical Document (CTD) format.

Now available for individual writers!

 

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Accessibility

eCTD-compliant templates can be selected and downloaded on demand via Acumen’s cloud-based interface.

Regulatory Guidance

Each template includes a summary of applicable regulatory guidance, specifically tailored to address requirements of Investigational New Drug Applications (IND), Biologics License Applications (BLA), New Drug Applications (NDA), Investigational Medicinal Product Dossiers (IMPD), and Marketing Authorization Applications (MAA). Links to the specific guidance ensures information is current and up-to-date so authors maintain compliance.

Writing Guidance and Support

Writing tips from Acumen’s experienced medical writers and editors are provided in many of our templates. Our guidance is based on years of experience and best practices in preparing submissions to help writers of all experience levels get things right the first time.

To minimize spelling errors, our templates come with an embedded dictionary to capture and correct medical and scientific terms that Microsoft Word does not recognize.

Applications

Acumen’s eCTD-compliant templates streamline document development for:

  • IND FDA submissions

  • NDA FDA submissions

  • BLA FDA submissions

  • IMPD EMA submissions

  • MAA EMA submissions

 

Ease of Use

Acumen’s eCTD templates integrate with the Stylus toolbar to make formatting fast and simple.

With Stylus, annoying and time-consuming formatting issues are resolved with a click:

  • Harmonizing numbering

  • Fixing messy tables

  • Adding hyperlinks to headings, tables and figures

Our writers and editors have thrown everything they know into this toolbar to save you time and make work easier.

Core features:

  • Authoring tips added by experienced regulatory writers

  • Links to pertinent regulatory guidance

  • Downloadable via a user web portal

  • Updated with the latest changes in regulatory guidance

  • Continued real-time access to individual templates

  • Syncs with the Acumen Stylus for easy implementation of consistent styles

More info:

  • View and download Templates Product Overview HERE

  • View and download sample Template HERE

Module detail

Click titles below to expand

 
 

Module 1 CA

  • 1.0.1 CA Cover Letter
  • 1.0.4 CA Health Canada Solicited Information
  • 1.0.7 CA General Note to Reviewer
  • 1.2.4.2 CA Data Protection Information
  • 1.3.1 CA Product Monograph
  • 1.3.4 CA Investigator Brochure
  • 1.3.7 CA Look-alike Sound-alike Assessment
  • 1.3.8.2 CA Risk Management Plan
  • 1.4.1 CA PSEAT-CTA
  • 1.5 CA Environmental Assessment Statement
  • 1.7.4 CA Information on Prior-related Applications
  • CA Clinical Study Protocol Phase I
  • CA Clinical Study Protocol Phase II-III

Module 1 EU

  • 1.0 EU Cover Letter
  • 1.3.4 EU Consultation with Target Patient Groups
  • 1.4.1 EU Information About the Experts Quality
  • 1.4.2 EU Information About the Experts NonClinical
  • 1.4.3 EU Information About the Experts Clinical
  • 1.5.1 EU Information for Bibliographical Applications
  • 1.5.2 EU Information for Generic Hybrid Bio-similar Applic
  • 1.5.3 EU Extended Data Market Exclusivity
  • 1.5.4 EU Exceptional Circumstance
  • 1.5.5 EU Conditional Marketing Authorisation
  • 1.6.1 EU Environmental Risk Assessment Non-GMO
  • 1.7.1 EU Information Relating to Orphan Market Exclusivity
  • 1.7.2 EU Information Relating to Orphan Market Exclusivity
  • 1.8.1 EU Pharmacovigilance System
  • 1.8.2 EU Risk Management Plan
  • 1.9 EU Information Relating to Clinical Trials
  • Core Data Sheet
  • EU Response to List of Questions
  • IMPD base template

Module 1 US

  • 1.10.1 Request for Dispute Resolution
  • 1.10.2 Correspondence Related to Dispute Resolution
  • 1.11.1 Quality Information Amendment
  • 1.11.2 Nonclinical Information Amendment
  • 1.11.3 Clinical Information Amendment
  • 1.11.4 Multiple Module Information Amendment
  • 1.12.1 Pre-IND Correspondence
  • 1.12.13 Request for Waiver for In Vivo Studies
  • 1.12.14 Environmental Assessment - Categorical Exclusion
  • 1.12.14 Environmental Assessment
  • 1.12.15 Request for Waiver for In Vivo Bioavailability Stu
  • 1.12.16 Field Alert Reports
  • 1.12.17 Orphan Drug Designation
  • 1.12.2 Request to Charge for Clinical Trial
  • 1.12.3 Request to Charge for Expanded Access
  • 1.12.4 Request for Comment_Advice
  • 1.12.5 Request for a Waiver
  • 1.12.6 Exemption from Informed Consent for Emergency Resea
  • 1.12.7 Public Disclosure Statement for Exemption from Info
  • 1.12.8 Correspondence Regarding Exemption from Informed Co
  • 1.12.9 Notification of Discontinuation of Clinical Trial
  • 1.13.1 Summary for Nonclinical Studies - IND Annual Report
  • 1.13.1 Summary for Nonclinical Studies - NDA Annual Report
  • 1.13.10 Foreign Marketing
  • 1.13.11 Distribution Data
  • 1.13.12 Status of Postmarketing Study Commitments and Requ
  • 1.13.13 Status of Other Postmarketing Studies and Requirem
  • 1.13.14 Log of Outstanding Regulatory Business - IND Annua
  • 1.13.14 Log of Outstanding Regulatory Business - NDA Annua
  • 1.13.15 Development Safety Update Report (DSUR)
  • 1.13.2 Summary for Clinical Pharmacology Information - IND
  • 1.13.2 Summary for Clinical Pharmacology Information - NDA
  • 1.13.3 Summary of Safety Information - IND Annual Report
  • 1.13.3 Summary of Safety Information - NDA Annual Report
  • 1.13.4 Summary of Labeling Changes
  • 1.13.5 Summary of Manufacturing Changes - IND Annual Repor
  • 1.13.5 Summary of Manufacturing Changes - NDA Annual Repor
  • 1.13.6 Summary of Microbiological Changes
  • 1.13.7 Summary of Other Significant New Information
  • 1.13.8 Individual Study Information
  • 1.13.9 General Investigational Plan
  • 1.14 Labeling - NDA Annual Report_Placeholder
  • 1.14.1.2 Annotated Draft Labeling Text
  • 1.14.1.4 Labeling Comprehension Studies
  • 1.14.1.5 Labeling History
  • 1.14.2.1 Final Carton and Container Labels
  • 1.14.2.2 Final Package Insert_Placeholder
  • 1.14.2.3 Final Labeling Text_Placeholder
  • 1.14.3.1 Annotated Comparison with Reference Listed Drug (
  • 1.14.3.2 Approved Labeling Text for Reference Listed Drug
  • 1.14.3.3 Labeling Text for Reference Listed Drug (RLD)
  • 1.14.4.1 Annual Report Investigational Brochure_Placeholde
  • 1.14.4.1 Investigator's Brochure
  • 1.14.4.2 Investigational Drug Labeling
  • 1.14.5 Foreign Labeling
  • 1.14.6 Product Labeling for 2253 Submissions
  • 1.15 General Considerations
  • 1.15 Presentation Issues
  • 1.15 Promotional Complaints
  • 1.15 Promotional Format for Electronic Submission
  • 1.15 Promotional Material Submitted in Fulfillment of the
  • 1.15 Promotional Materials Paper Hard Copy
  • 1.15.1.1 Request for Advisory Comments on Launch Materials
  • 1.15.1.10 Submission of Annotated References
  • 1.15.1.11 General Correspondence
  • 1.15.1.3 Presubmission of Launch Promotional Meterials for
  • 1.15.1.4 Presubmission of Non-Launch Promotional Materials
  • 1.15.1.5 Pre-dissemination Review of Television Ads
  • 1.15.1.6 Response to Untitled Letter or Warning Letter
  • 1.15.1.7 Response to Information Request
  • 1.15.1.8 Correspondence Accompanying Materials Previously
  • 1.15.1.9 Withdrawal Request
  • 1.16 Proposed Risk Evaluation and Mitigation Strategies (R
  • 1.16 Proposed Risk Evaluation and Mitigation Strategies (R
  • 1.16 Proposed Risk Evaluation and Mitigation Strategies (R
  • 1.16 Risk Management Plans
  • 1.16.2.1 Final REMS_Placeholder
  • 1.16.2.2 Draft REMS_Placeholder
  • 1.16.2.3 Risk Evaluation and Mitigation Strategies (REMS)
  • 1.16.2.4 Risk Evaluation and Mitigation Strategies (REMS)
  • 1.16.2.5 Risk Evlauation and Mitigation Strategies (REMS)
  • 1.16.2.6 Risk Evlauation and Mitigation Strategies (REMS)
  • 1.17.1 Correspondence Regarding Postmarketing Commitments
  • 1.17.2 Correspondence Regarding Postmarketing Requirements
  • 1.19 Emergency Use Authorization Request
  • 1.2 Cover Letter - Initial IND Application
  • 1.2 Cover Letter - Original NDA Application
  • 1.2 Reviewer Guide
  • 1.20 General Investigational Plan for Initial IND-2
  • 1.20 General Investigational Plan for Initial IND
  • 1.3.1.1 Change of Address
  • 1.3.1.2 Change of Contact Agent
  • 1.3.1.3 Change of Sponsor
  • 1.3.1.4 Transfer of Obligation
  • 1.3.1.5 Change in Ownership of an Application or Reissuanc
  • 1.3.2 Field Copy Certification
  • 1.3.3 Debarment Certification
  • 1.3.4 Financial Certification and Disclosure
  • 1.3.5.1 Patent Information_Placeholder
  • 1.3.5.2 Patent Certifications
  • 1.3.5.3 Exclusivity Claim
  • 1.3.6 Tropical Disease Piority Review Voucher
  • 1.4.1 Letter of Authorization_Placeholder
  • 1.4.2 Statement of Right of Reference_Placeholder
  • 1.4.4 Cross-reference to Previously Submitted Information
  • 1.5.1 Withdrawal of IND
  • 1.5.2 Inactivation Request
  • 1.5.3 Reactivation Request
  • 1.5.4 Reinstatement Request
  • 1.5.5 Withdrawal of an Unapproved Application
  • 1.5.6 Withdrawal of a Listed Drug
  • 1.5.7 Request for Withdrawal of Application Approval or Re
  • 1.6.1 Meeting Request
  • 1.6.1 Meeting Request_Biosimilar_Biologics
  • 1.6.2 Pre-IND Meeting Background Materials
  • 1.6.2 Pre-NDA Meeting Background Materials
  • 1.6.3 Correspondence Regarding Meetings-1
  • 1.7.1 Fast Track Designation
  • 1.7.2 Fast Track Designation Withdrawal Request
  • 1.7.3 Rolling Review Request
  • 1.8.1 Special Protocol Assessment Request_Clinical Study
  • 1.8.2 Special Protocol Assessment_Carcinogenicity Study
  • 1.8.2 Special Protocol Assessment_Carcinogenicity_Intent N
  • 1.8.3 Special Protocol Assessment Request_Stability Study
  • 1.9.1 Request for Waiver of Pediatric Studies
  • 1.9.2 Request for Deferral of Pediatric Studies
  • 1.9.4 Pediatric Study Plan
  • 1.9.6 Other Correspondence Regarding Pediatric Exclusivity
  • Breakthrough Therapy Designation
  • Clinical Data - NDA Annual Report_Placeholder
  • CMC - NDA Annual Report_Placeholder
  • Core Data Sheet - 1
  • IB Update Summary of Changes
  • Nonclinical Studies - NDA Annual Report_Placeholder
  • Paper IND to eCTD Conversion_Cover Letter
  • Phase I Protocol Modifications - IND Annual Report_Placeho
  • Physician's Labeling Rule_Content
  • Request for Proprietary Name Review
  • Target Product Profile

Module 2 Summaries

  • 2.2 Introduction to Summary - IND
  • 2.2 Introduction to Summary
  • 2.3 Introduction to the Quality Overall Summary
  • 2.3.A.1 Facilities and Equipment
  • 2.3.A.2 Adventitious Agents Safety Evaluation
  • 2.3.A.3 Novel Excipients
  • 2.3.P Drug Product Non-granular
  • 2.3.P.1 Description and Composition of the Drug Product
  • 2.3.P.2 Pharaceutical Development
  • 2.3.P.3 Manufacture
  • 2.3.P.4 Control of Excipients
  • 2.3.P.5 Control of Drug Product
  • 2.3.P.6 Reference Standards or Materials
  • 2.3.P.7 Container Closure System
  • 2.3.P.8 Stability
  • 2.3.R Regional Information
  • 2.3.S Drug Substance Non-granular
  • 2.3.S.1 General Information
  • 2.3.S.2 Manufacture
  • 2.3.S.3 Characterization
  • 2.3.S.4 Control of Drug Substance
  • 2.3.S.5 Reference Standards or Materials
  • 2.3.S.6 Container Closure System
  • 2.3.S.7 Stability
  • 2.3A Appendices Non-granular
  • 2.4 Nonclinical Overview
  • 2.5 Clinical Overview
  • 2.6.1 Introduction
  • 2.6.2 Pharmacology Written Summary
  • 2.6.3 Pharmacology Tabulated Summary
  • 2.6.4 Pharmacokinetics Written Summary
  • 2.6.5 Pharmacokinetics Tabulated Summary
  • 2.6.6 Toxicology Written Summary
  • 2.6.7 Toxicology Tabulated Summary
  • 2.7.1 Summary of Biopharmaceutic Studies and Associated An
  • 2.7.2 Summary of Clinical Pharmacology Studies
  • 2.7.3 Summary of Clinical Efficacy
  • 2.7.4 Summary of Clinical Safety
  • 2.7.5 References
  • 2.7.6 Synopses of Individial Studies

Module 3 Quality

  • Granular Module 3 Templates
  • 3.2.A.1 Facilities and Equipment
  • 3.2.A.2 Adventitious Agents Safety Evaluation
  • 3.2.A.3 Excipients
  • 3.2.P.1 Description and Composition of the Drug Product No
  • 3.2.P.2 Pharmaceutical Development Non-granular
  • 3.2.P.2.1 Components of the Drug Product non-granular
  • 3.2.P.2.2 Drug Product Non-granular
  • 3.2.P.2.3 Manufacturing Process Development
  • 3.2.P.2.4 Container Closure System
  • 3.2.P.2.5 Microbiological Attributes
  • 3.2.P.2.6 Compatibility
  • 3.2.P.3.1 Manufacturers
  • 3.2.P.3.2 Batch Formula
  • 3.2.P.3.3 Description of Manufacturing Process and Process
  • 3.2.P.3.4 Controls of Critical Steps and Intermediates
  • 3.2.P.3.5 Process Validation and-or Evaluation
  • 3.2.P.4.1 Specifications Non-granular
  • 3.2.P.4.2 Analytical Procedures-Test Method
  • 3.2.P.4.2 Analytical Procedures
  • 3.2.P.4.3 Validation of Analytical Procedures
  • 3.2.P.4.4 Justification of Specifications
  • 3.2.P.4.5 Excipients of Human or Animal Origin
  • 3.2.P.4.6 Novel Excipients
  • 3.2.P.5.1 Specifications
  • 3.2.P.5.2 Analytical Procedures-Test Method
  • 3.2.P.5.2 Analytical Procedures
  • 3.2.P.5.3 Validation of Analytical Procedures-Test Method
  • 3.2.P.5.3 Validation of Analytical Procedures
  • 3.2.P.5.4 Batch Analyses Non-granular
  • 3.2.P.5.5 Characterization of Impurities
  • 3.2.P.5.6 Justification of Specifications
  • 3.2.P.6 Reference Standards or Materials
  • 3.2.P.7.1 Container Closure System Non-granular
  • 3.2.P.7.2 Container Closure System-Secondary Packaging
  • 3.2.P.8.1 Stability Summary and Conclusion Non-granular
  • 3.2.P.8.2 Postapproval Stability Protocol and Stability Co
  • 3.2.P.8.3 Stability Data Non-granular
  • 3.2.R Regional Information_Placeholder
  • 3.2.R.2 Methods Validation Package
  • 3.2.S.1.1 Nomenclature
  • 3.2.S.1.2 Structure
  • 3.2.S.1.3 General Properties
  • 3.2.S.2.1 Manufacturers
  • 3.2.S.2.2 Description of Manufacturing Process and Process
  • 3.2.S.2.3 Control of Materials Non-granular
  • 3.2.S.2.4 Control of Critical Steps and Intermediates Non-
  • 3.2.S.2.5 Process Validation and-or Evaluation
  • 3.2.S.2.6 Manufacturing Process Development
  • 3.2.S.3.1 Elucidation of Structure and Other Characteristi
  • 3.2.S.3.2 Impurities Non-granular
  • 3.2.S.4.1 Specification
  • 3.2.S.4.2 Analytical Procedures-Test Method
  • 3.2.S.4.2 Analytical Procedures
  • 3.2.S.4.3 Validation of Analytical Procedures-Test Method
  • 3.2.S.4.3 Validation of Analytical Procedures
  • 3.2.S.4.4 Batch Analyses
  • 3.2.S.4.5 Justification of Specification
  • 3.2.S.5 Reference Standards or Materials
  • 3.2.S.6 Container Closure System
  • 3.2.S.7.1 Stability Summary and Conclusions Non-granular
  • 3.2.S.7.2 Post-approval Stability Protocol and Stability C
  • 3.2.S.7.3 Stability Data Non-granular
  • 3.3 Literature References_Placeholder

Module 4 Safety

  • 4.3 Literature References_Placeholder
  • In Vitro Pharmacology Study Report
  • In Vivo Pharmacology Study Report
  • Pharmacokinetic Study Report
  • Toxicology Protocol
  • Toxicology Study Report

Module 5 Efficacy

  • 16.1.1 Protocol and Amendments
  • 16.1.10 Inter-Laboratory Standardization Methods and Quali
  • 16.1.11 Publications Based on the Study
  • 16.1.12 Publications Referenced in the Study
  • 16.1.2 Sample CRF
  • 16.1.3 IEC and IRB and Consent Form Listings
  • 16.1.4 Description of Investigators and Sites
  • 16.1.5 Investigator Signatures
  • 16.1.6 Listing of Patients from Specified Batches
  • 16.1.7 Randomization Scheme
  • 16.1.8 Audit Certificate
  • 16.1.9 Statistical Methods and Interim Analysis Plans
  • 16.2.1 Discontinued Patients
  • 16.2.2 Protocol Deviations
  • 16.2.3 Patients Excluded from Efficacy Analysis
  • 16.2.4 Demographic Data
  • 16.2.5 Compliance and Drug Concentration Data
  • 16.2.6 Individual Efficacy Response Data Phase II-III
  • 16.2.6 Individual Pharmacokinetics Response Data Phase I
  • 16.2.7 Adverse Event Listings
  • 16.2.8 Individual Laboratory Measurements
  • 16.3.1 CRFs for Deaths, SAEs, and Withdrawals
  • 16.3.2 Other CRFs
  • 5.2 Tabular Listing of All Clinical Studies
  • 5.3.6 Reports of Post-Marketing Experience
  • 5.4 Literature References_Placeholder
  • Abbrev-16.1.1 Protocol and Amendments
  • Abbrev-16.1.2 Sample CRF
  • Abbrev-16.2.7 Adverse Event Listings
  • Abbrev-16.3.1 CRFs for Deaths, SAEs, and Withdrawals
  • Abbrev-Clinical Study Report_granular body
  • Abbrev-Synopsis
  • Amendment Summary of Changes_Complex Option
  • Amendment Summary of Changes_Simple Option
  • Clinical Study Protocol Phase I
  • Clinical Study Protocol Phase II-III
  • Clinical Study Report_granular body Phase I
  • Clinical Study Report_granular body Phase II-III
  • General Protocol Template
  • Integrated Summary of Efficacy
  • Integrated Summary of Safety
  • PBRER
  • Periodic Safety Update Report
  • SAP ISE
  • SAP ISS
  • SAP Phase I
  • SAP Phase II-III

ANDA

  • 1.12.11 Basis for Submission_ANDA
  • 1.12.12 Comparison Between Generic Drug and Reference
  • 1.12.14 Environmental Assessment_ANDA
  • 1.12.15 Request for Waiver of In Vivo Bioavailability
  • 1.14.1.2 Annotated Draft Labeling Text_ANDA
  • 1.14.3.1 Annotated Comparison with Listed Drug_ANDA
  • 1.3.3 Debarment Certification_ANDA
  • 1.3.5.2 Patent Certification_ANDA
  • 2.3 Introduction to Quality Overall Summary_ANDA
  • 2.3 Quality Overall Summary_ANDA
  • 2.3.P.1 Description and Composition of the Drug Produ
  • 2.3.P.2 Pharmaceutical Development_ANDA
  • 2.3.P.3 Manufacture_ANDA
  • 2.3.P.4 Control of Excipients_ANDA
  • 2.3.P.5 Control of Drug Product_ANDA
  • 2.3.P.6 Reference Standards or Materials_ANDA
  • 2.3.P.7 Container Closure System_ANDA
  • 2.3.P.8 Stability_ANDA
  • 2.3.S.1 General Information_ANDA
  • 2.3.S.2 Manufacture_ANDA
  • 2.3.S.3 Characterization_ANDA
  • 2.3.S.4 Control of Drug Substance_ANDA
  • 2.3.S.5 Reference Standards or Materials_ANDA
  • 2.3.S.6 Container Closure System_ANDA
  • 2.3.S.7 Stability_ANDA
  • 2.7.1 Summary of Biopharmaceutic Studies and Associat
  • Bioequivalence Summary Data Tables_ANDA