CMC Documentation and AI in Regulatory Affairs

Introduction

Features

Related Courses

Who should attend

About CMC Writing

CMC Writing Vs. CMC AI Course

The Post Graduate Certification in CMC Documentation & AI in Regulatory Affairs by Royed Training is a specialized online program designed to prepare future-ready regulatory professionals.

At the beginning, the course introduces participants to the fundamentals of regulatory affairs and the critical role of CMC (Chemistry, Manufacturing, and Controls) in global drug development. Next, learners progress step-by-step into authoring, reviewing, and managing CMC documentation across multiple markets. Importantly, the curriculum not only covers ICH guidelines, CTD/eCTD submissions, and Quality Overall Summaries, but also explains practical aspects of lifecycle management, variations, and regulatory queries.

Moreover, as the pharmaceutical industry continues to evolve, the course highlights how Artificial Intelligence is transforming regulatory affairs. Therefore, participants gain exposure to AI-driven dossier automation, labeling harmonization, risk prediction, and data integrity solutions. In addition, learners engage with real-world case studies, simulations, and capstone projects that bridge the gap between theory and industry application.

As a result, graduates of this program develop dual expertise:

Strong foundation in CMC authoring and global regulatory compliance
Practical ability to apply AI tools for faster, smarter, and more accurate regulatory submissions

Finally, the program concludes with a capstone project and mock regulatory defense, ensuring participants are fully prepared to face real-world regulatory challenges with confidence.

Equipping regulatory professionals with dual mastery: world-class CMC documentation skills and future-ready AI-powered regulatory expertise.

Course Snapshots:

Course Code: RYD-140
Title of the course: PG Certification in CMC Documentation and AI in Regulatory Affairs
Duration: 1 Year
Nature of the course: Online learning course. So the course can be accessed online anywhere 24×7.
Eligibility : Graduation in any discipline. Even final year graduation students can apply.
Course Certificate: Certificate will be provided at the end of the successful completion of the course.

This online course utilizes interactive learning tools to guide each participant through the steps of CMC Writing process for different regulatory bodies and practical exposure in pre and post submission management. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Features of the Course:

Comprehensive Curriculum – Covers CMC documentation for small molecules, biologics, and biosimilars along with AI applications in regulatory affairs.
Self-Paced Learning – 100% online, flexible access with 24×7 availability from anywhere.
Learn at Your Own Pace – Start, pause, and resume anytime, ensuring learning fits around professional schedules.
‍ Interactive Learning – Includes lectures, case studies, real-world simulations, and practical assignments.
Global Regulatory Coverage – Insights on FDA, EMA, MHRA, PMDA, TGA, SFDA, GCC, and other international regulatory frameworks.
AI Integration – Hands-on training on AI-powered dossier preparation, labeling alignment, risk prediction, and regulatory intelligence tools.
Capstone Project – End-to-end CMC dossier preparation with AI assistance, plus mock regulatory defense.
Royed PG Certification – Globally recognized credential upon successful completion.
‍ Industry-Oriented – Designed with practical focus, minimal theory, and application-driven content.
Career Advancement – Equips learners with dual expertise in traditional CMC authoring and future-ready AI regulatory skills.

Key Points to Note:

100% Online & Self-Paced – 24×7 access, learn anytime, anywhere. This program is delivered as an online, self-paced training. Therefore, participants can access the course 24×7 from anywhere in the world. Moreover, the flexible design allows learners to progress at their own speed. Hence, the course can be completed at any pace, enabling participants to start, pause, and resume their learning journey at their convenience.
Focus on eCTD v4.0 – Gain practical skills in next-generation electronic submissions.
AI-Powered Training – Learn how AI transforms CMC documentation and regulatory affairs.

Some related courses

CMC Writing training content is also part of the International Drug Regulatory Affairs (EPGIDRA) and Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course. Therefore, a separate course is not required if you already taking EPGIDRA or PGDBMRA course. We also have dedicated Drug Dossier Preparation course which covers the CMC writing.

This program is ideal for professionals who want to advance their careers in regulatory affairs and CMC documentation while mastering AI-powered tools:

‍Regulatory Affairs Professionals – seeking to enhance their dossier preparation and submission skills.
CMC Writers & Technical Authors – aiming to improve their expertise in Module 3 authoring and QOS preparation.
Pharma & Biopharma R&D Professionals – who need to understand regulatory documentation requirements.
Quality Assurance & Compliance Managers – focusing on data integrity, lifecycle management, and regulatory expectations.
AI & Digital Transformation Enthusiasts – interested in applying AI/ML, NLP, and automation tools in regulatory processes.
Graduates & Postgraduates in Life Sciences/Pharmacy – aspiring to build a career in global regulatory affairs.

Things about CMC Writing you must know.

At Royed Training platform we have two different CMC training course to Transform into a Next-Generation Regulatory Professional!

1-Year PG Certification in CMC Documentation & AI in Regulatory Affairs – Comprehensive program covering global frameworks, AI integration, eCTD v4.0, case studies, simulations, and capstone projects.
⏳ 1-Month Certification in Regulatory CMC Writing – Focused, fast-track course for professionals looking to strengthen skills in Module 3 authoring, QOS preparation, and global submission writing.

Here is the differences between deep dive with CMC+ AI career-defining expertise (1 Year) or a practical quick-skill boost (1 Month) cmc writing training.

CMC+AI Vs. CMC Writing Course Comparison

Feature	🎓 PG Certification in CMC Documentation & AI in Regulatory Affairs	⏳ Advanced Certification in Regulatory CMC Writing
Duration	12 Months	1 Month
Mode	100% Online, Self-Paced, 24×7 Access	100% Online, Self-Paced, 24×7 Access
Focus	Comprehensive training in CMC documentation (small molecules, biologics, biosimilars) + AI integration, global frameworks, lifecycle management, eCTD v4.0	Focused training on CMC writing – Module 3, QOS, analytical validation & global submission writing
Certification	Royed PG Certification (Globally Recognized)	Royed Certification in Regulatory CMC Writing
Best For	Regulatory affairs professionals seeking career-defining expertise and future-ready AI skills	Professionals needing a quick upskilling in CMC authoring and dossier preparation

Section 1Drug Discovery and Development Fundamental

Lecture 1R&D Process & Introduction to drug discovery

Lecture 2Investigational New Drug Application (INDA)

Lecture 3New Drug Application (NDA)

Lecture 4Basic concept and understanding of the Generic Drug

Lecture 5Abbreviated New Drug Application (ANDA) Filing

Lecture 6Exploratory IND Vs. Traditional IND

Lecture 8USFDA expedited programs

Lecture 9EMA and EMA Authorisation Process

Lecture 10EU MA Procedure - Centralised, Decentralised, Mutual Recognition, National Procedure

Lecture 11IMPD | Significance | Format of IMPD | Differences with CTA, IB, IND

Lecture 12Investigator’s Brochure | Significance | Format of IB | Preparing different sections of IB

Lecture 13Data Exclusivity and Market Protection - Supplementary Patent Protection, Exclusivity, 6/10 Rule, 8+2+1 Formulae

Section 2Preformulation Studies

Lecture 14Preformulation Study in Drug Development

Lecture 15Regulatory Requirements for Preformulation Study

Lecture 16Logical Sequence of Preformulation Study | Case Insights | Strategies for preformulation studies

Section 3Regulatory Requirements for Non-Clinical Studies

Lecture 17Regulatory Requirements for Non-clinical Studies | Types of Non-clinical studies

Lecture 18Types and Timing of Non-clinical Studies

Section 4Regulatory Requirements for Clinical Studies

Lecture 19Understanding on Clinical Trials and Clinical Research

Lecture 20Clinical Trial Protocol Writing

Lecture 21Ethics in Clinical Research

Lecture 22Informed Consent | Practical Training on preparing ICF | Ready Templates

Section 5ICH Guideline

Lecture 23Introduction to ICH | Members | Guidelines

Lecture 24ICH Q1 : Stability Guideline | Matrixing | Bracketing

Lecture 25ICH Q2 : Analytical Validation

Lecture 26ICH Q3 : Impurities

Lecture 27Rest of ICH Q Family Guidelines

Section 6Managing CMC requirements

Lecture 28Chemistry, Manufacturing & Controls

Lecture 29Fundamental of CMC | Detailed understanding of CMC section writing | Important Points regarding CMC | Drug Product and Drug Substance | Excipient, FP, Analysis and Stability Study Requirements

Lecture 30505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA

Lecture 31Advance Learning on 505B2 Pathway

Lecture 32EU MA Application Types and Strategic Planning

Section 7Dossier Preparation

Lecture 33Introduction to Common Technical Document (CTD)

Lecture 34CMC Dossier & Compliance Management

Lecture 35Key Consideration for Drug Master File Preparation and Submission

Lecture 36Practical Understanding on Drug Master File Preparation and Submission

Lecture 37Associated Learning: Site Master File - Detailed Understanding

Lecture 38Drug Master File - Fees

Lecture 39Drug Master File - Global Perspective [Across Different Regions]

Lecture 40Electronic Common Technical Document (ECTD)

Lecture 41Certificate of Analysis

Lecture 42Asean Common Technical Document (ACTD)

Lecture 43Grouped Submission | Significance | Importance in Market Access and Regulatory point of view | Case Study

Section 8Dossier Submission and Management

Lecture 44FDA Forms and How to fill the resources

Lecture 45Strategic Discussion: PreIND, EOP1, EOP2 - What to expect !

Lecture 46Importance of effective dossier management

Lecture 47Discussion on 85 common deficiencies in CTD submission dossier

Lecture 48Detailed Understanding on ANDA Submission Dossier

Lecture 49Prior Approval Submission

Lecture 50Detailed Understanding on ANDA Fees

Lecture 51Detailed Understanding on 505(b)(2) VS. Suitability Petition : Case Based Learning

Lecture 52NCE Vs. 505b2 application - Case Based Learning

Lecture 53FTF - 180 Days Exclusivity - Case Based Learning

Lecture 54Classic case study of the 505b2 filing : Case Based Learning

Lecture 55EU MA Strategic Planning: Full, Full-mixed, hybrid applications. Generic, Similar biologic application pathway, Well-established use application, Fixed combination application, Informed consent application

Lecture 56Supplemental New Drug Application (sNDA) | Filing and Submission Management | Requirements | Best Practices | Different Forms for sNDA submissions

Lecture 57OGD Table - How to Prepare | Sample Tabular Summary Preparation

Section 9Stability Study

Lecture 58Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study

Lecture 59

Lecture 60Stability Zone Finder

Lecture 61Stability Studies : Case discussions

Lecture 62Stability Data for Zone IV countries

Lecture 63Accelerated and intermediate testing conditions

Lecture 64Long Term Stability Testing Requirements

Lecture 65Stability Study Protocol Development - Dosage form: Capsule

Lecture 66Stability Data Sheet

Lecture 67Dossier Stability Test

Lecture 68Testing Frequency

Lecture 69Bracketing

Lecture 70Matrixing

Section 10BA BE Study

Lecture 71PKPD in Drug Discovery | PK-PD trial | Understanding PKPD from regulatory perspective in drug approval process

Lecture 72Bioequivalence Study | Study design | Different types of BE Studies

Lecture 74Biopharmaceutical Classification System (BCS) | Types | Biowaivers | BCS tool for drug development and regulatory submission

Lecture 75Bioequivalence Study - Discussion - Timeline of stability study and bioequivalence study

Lecture 76Bioequivalence Study - Discussion - Dissolution Testing

Lecture 77Bioequivalence Study - Generic Approval and Additives Labeling Requirements

Lecture 78BA BE Study Design | Comparing different types of the study design

Lecture 792wco Study Design | Design Table | Importance

Lecture 803wco Study Design | Design Table | Importance

Lecture 81FRCO Study Design | Design Table | Importance

Lecture 82OGD Table - How to Prepare | Sample Tabular Summary Preparation

Section 11Post Approval Changes and Variation Management

Lecture 83Variation Management | Reasons for Variation | Working in Variation Department

Lecture 84Variation Classification | Basis of Classification | US and EU Variation Classification | Other region variation guideline

Lecture 85EU variation -Types, Requirement & Planning - IA, IAIN, IB, II ; US FDA Variation AR, CBE-0, CBE-30, PAS - Strategic Discussion | Similarities & Differentiation

Lecture 86Impact Assessment in CMC Writing | Case Based Discussion| Scenario Decision Making

Section 12Quality Issues | Post Filing Regulatory Queries | Response to Queries (RTQs) | Critical Issues in Submission Management

Lecture 87Data Integrity issues in Pharmaceutical Industry : Detailed Understanding

Lecture 88Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 89Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity

Lecture 90RTQs | Response to Queries | How to handle Regulatory Queries

Section 13Biologic CMC Requirements

Lecture 91Biosimilar Development Process

Lecture 92Strategic Consideration for Biosimilar Development

Lecture 94Studies required for approval of biosimilar

Lecture 95Comparability of Biologics | Different Categories of Comparability | General Principles

Section 14Differentiating CMC and Regulatory Writing with Medical and Scientific Writing

Lecture 96Introduction to Medical Writing | Objective | Significance | Medical Writing Vs. Scientific Writing | Key Notes

Lecture 97Types of Medical Writing | Regulatory Writing | CMC Writing | Clinical Writing | Documents under each class of medical writing

Lecture 98Ethical Consideration of Medical Writing | Important Considerations | Effective strategies for each ethical consideration | Case studies

Lecture 99Regulatory Documents | Classification of regulatory documents | Understanding of each class of documents | Ethical consideration for Regulatory Writing

Lecture 100Publication Writing and Regulatory Writing | Key Differences with Examples

Lecture 101Regulatory Writing - Review Test

Lecture 102Hands on Case Study Protocol Designing for Experimental Asthma Drug | Analysis of various aspect of protocol | Open File

Lecture 103Drafting of Study Objective Methodology and Endpoint | Checklist

Section 15Reference | Discussions | CMC Case Studies

Lecture 104Comparison of Requirement of Various Regulatory Bodies

Lecture 105Comparison of Dossier Requirements of Europe and US

Lecture 106Comparison of DMF requirement of various regulatory bodies

Lecture 107ICH Guidelines - Comprehensive View

Lecture 108ICH CTD Top Level View with Notes and Explanation

Lecture 109Comparison of ICH US EU CTD

Lecture 110Regulatory Documents - At a glance

Lecture 111Structured CMC Writing Checklist

Lecture 112CMC Writing Case Study | Successful Documentation

Lecture 113Structure for CMC Writing | Understanding 3.2.S and 3.2.P section | Documents requirements | Case Study

Lecture 114Well written Vs. Poorly Written CMC Section | Practical Example

Lecture 115Drug Substance Section in CMC | Documentations | Practical Examples | Do’s and Don’ts

Lecture 116Example of Well-Written Drug Substance Characterization | Impurities and Degradation Products | Well-Written Impurities and Degradation Products | Synthesis and Manufacturing Processes | Control of Drug Substance (Specifications, Testing, and Acceptance Criteria)

Lecture 117Stability Studies and Data Presentation in CMC Writing | Case Based Analysis of Stability Study Data Presentation | Interpretation of stability data

Lecture 118Certificate of Suitability (CEP) | Significance | Importance | Understanding Regulatory Compliance and Submission Process | Walkthrough

Lecture 119CEP Dossier DMF - Differences

Lecture 120Developing Specifications for a New API

Lecture 121Example of Manufacturing Process and Controls

Lecture 122Interpretation of Stability Table

Lecture 123Critical Stability Scenarios | 8 Different Case Studies | Stability Study - Outcome based action plan creation

Lecture 124Critical Stability Issues - Database | Implication | Action Plan

Lecture 125Policy 0070 | RPDP Submission and Management timeline | Anonymisation Report (AnR) - Significance | AnR in FRDP

Lecture 126Common Pitfalls in CMC Writing and How to Avoid Them | Case Study

Lecture 127Process Validation Report (PVR) | Sample Process Validation Report Analysis | CPPs and CQAs identification

Lecture 128Case Study - Omissions of CPPs in PVR | Case insight, explanation, action plan | Correlations - CPPs - CQAs - IPCs

Lecture 129Binding and Non-binding legal considerations - Module 3 Quality in CMC Section | Case Studies

Lecture 130Binding and Non-binding Scenarios with Examples

Section 16WHO Certification Scheme | Documentation

Lecture 131Introduction to Certificate of Pharmaceutical Product | Types of CoPP | List of Countries / Regulatory Authorities who requires CoPP | CoPP as a part of generic market expansion planning

Lecture 132WHO-GMP Certification Scheme

Lecture 133Template of Certificate of Pharmaceutical product | Key observations and points to note while working on CoPP

Lecture 134WHO Prequalification Status : Significance | Strategic Importance | Submission Process | WHO PQ Documentation | Case study on WHO PQ submission management

Lecture 135WHO EML Vs. WHO PQ | Significance | Importance in Market Access and Regulatory point of view

Section 17Fundamental of AI in CMC Documentation

Lecture 136Introduction to AI

Lecture 137Basics of AI ML DL | Key Differences | Application in industry

Lecture 138Types of AI

Lecture 139AI Project | Overview

Lecture 140Comprehensive Training on AI Project | Managing Stages | AI Iteration

Lecture 141How machine learning

Lecture 142Understanding Regulatory Affairs – Traditional vs. Digital | 2 Case Study

Lecture 143Basics of AI for Regulatory Professionals | Understanding different models used in RA | Case Study | Simulation

Lecture 144AI Application across drug life cycle | Case Analysis | Model predictions

Lecture 145AI Terms with Regulatory Significance | Regulatory Applications

Lecture 146NLP in Regulatory Affairs | Conceptual understanding | Usage | NLP in Labeling

Lecture 147Data Grouping with Unsupervised Learning | Case Simulation | Hands on Exercise

Lecture 148Quality Data and Bias | Bias in datasets | Different Types of Bias in Pharma Datasets

Lecture 149AI Data Quality Standard | Checklist

Lecture 150Download AI Data Quality Checklist

Lecture 151Case Study: Accelerated Approval Using Real-World Evidence AI

Lecture 152AI Model for Dossier Submission and Filing - Model Selection | Simulation

Lecture 153AI Technologies in RA

Lecture 154Structured Vs. Unstructured Data | Practical Understanding | Explore Patient Datasets

Lecture 155Sample Data Exercise | Data error | Data Refinement and Cleaning of the data

Section 18AI in Regulatory Authoring and CMC Writing

Lecture 156AI-Powered Regulatory Document Authoring and CMC Writing

Lecture 157AI Tools Comparison - Authoring and CMC Writing (Module 2 & 3)

Lecture 158Tips for Selecting AI Tools (CMC Authoring)

Lecture 159CMC - AI Workflow Checklist | Simulation Based Cases

Lecture 160HITL Regulatory Document Authoring

Lecture 161Confidence Score in Regulatory Authoring | Case Simulation in CMC Authoring

Lecture 162Confidence Scores in Data Extract in Regulatory Writing [Case Simulation]

Section 19eCTD v4.0 Training

Lecture 163eCTDV4.0 Fundamental Understanding | Structures | Key Features

Lecture 164eCTDV4.0 Structure | Lifecycle Management

Lecture 165eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management

Lecture 166eCTD Validation Tools

Lecture 167eCTD Publishing Cycle

Lecture 168HL7 - Structure and Understanding in the context of eCTD V4.0

Lecture 169Tips and Submission Readiness Checklist

Lecture 170eCTD Submission Checklist Format

Section 20Risk and Compliance Management

Lecture 171AI and Data Integrity | Regulatory Documentation | Case Based Learning | Understanding Data Integrity Principles | Application and Use Cases

Lecture 172Cases of data breaches with explanation

Lecture 173Case Based Discussion : Data Breach in AI-Assisted CMC Drafting

Section 21CCDS - Labelling and Artwork Management

Lecture 174CCDS Management

Lecture 175CCDS Management Tools - Native, AI Plus | Key Functionalities

Lecture 176AI Augmented Labelling Compliance System

Lecture 177Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management

Lecture 178AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations

Lecture 179CCDS Management Case Study | Pregnancy Warning Upgrade Case Study

Lecture 180CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis

Lecture 181Centralized Artwork Operation | Mechanism | Operation Step Planning

Lecture 182Case Study on Centralized Artwork Operation [Recall Management]

Lecture 183Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases

Section 22 Real World Evidence and Real World Data | Strategic Decision Making

Lecture 184Evidence Based Decision Making | Combine evidences for decision making | Do we need more evidence?

Lecture 185RWD and RWE | Potential sources of RWE | Traditional RCTs vs. RWE | Case Study - RWE Programs | Influencing HCP decision-making

Lecture 186RWD and RWE in Product Lifecycle Management

Lecture 187RWD and RWE - Fit to use | Assessment

Lecture 188RWD data sources | Different types | Detailed understanding of each class

Lecture 189RWD Study Design

Lecture 190RWE Published Tool | Insights on commonly used tools

Lecture 191Healthcare Reimbursement Models : Value Based Care | Fee for Service (FFS) Model | Other Reimbursement Models

Lecture 192Consensus Narrative Review

Lecture 193Electronic Patient Data | EMR | EHR | Differences | Software architecture and characteristics

Lecture 195RWD Characteristics

Lecture 196RCT vs. RWE Comparison | Case Based Analysis

Lecture 197RCT and RWE Comparison

Section 23Working on Healthcare Datasets

Lecture 198Introduction to Healthcare Datasets

Lecture 199Dataset 1: Claims Data (Insurance)

Lecture 200Dataset 2: Retail Pharmacy Prescription Data

Lecture 201Dataset 3: Longitudinal Patient Data

Lecture 202Characteristics of Different Set of Healthcare Data

Lecture 203Reimbursement and Pricing Datasets

Lecture 204RWE Data Sources & Quality Considerations Checklist | Case Based Analysis

Lecture 205Triangulation and benchmarking | Enhancing Data Validation Through Cross-Referencing

Lecture 206RWD & RWE Case Database

Lecture 207RWE Large Dataset for Data Crunching Exercises |Data cleaning & preprocessing | Comparative Effectiveness Analysis

Section 24AI Tools, Ethics and Future Landscape

Lecture 208AI Reg Tools - Review | Understanding Capabilities

Lecture 209Regulatory Authority View on AI Adoption

Section 25Course Certification

CMC Documentation and AI in Regulatory Affairs

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Introduction

Features

Related Courses

Who should attend

About CMC Writing

CMC Writing Vs. CMC AI Course

Course Snapshots:

Features of the Course:

Key Points to Note:

Some related courses

Things about CMC Writing you must know.

CMC+AI Vs. CMC Writing Course Comparison

CMC Documentation and AI in Regulatory Affairs

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Introduction

Features

Related Courses

Who should attend

About CMC Writing

CMC Writing Vs. CMC AI Course

Course Snapshots:

Features of the Course:

Key Points to Note:

Some related courses

Things about CMC Writing you must know.

CMC+AI Vs. CMC Writing Course Comparison