InstructorRoyed Training
TypeOnline Course
Price$490USD / 27500 INR.
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nutraceutical regulatory affairs


Course Outline

Who should attend


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About Nutraceutical Regulatory Affairs

nutraceutical regulatory affairs training

This online certification course in Nutraceutical Regulatory Affairs provides a comprehensive overview of the regulatory landscape governing nutraceutical products worldwide. Participants will gain a deep understanding of the regulatory requirements, guidelines, and processes necessary for the development, manufacturing, and marketing of nutraceuticals. The course covers essential topics such as regulatory frameworks (e.g., FDA, EFSA, FASSI), ingredient safety assessment, labeling requirements, and compliance strategies.

Therefore this advanced certification course imparts training to create an effective Nutraceutical Regulatory Affairs professionals.

Nutraceutical training gives practical knowledge and real life job simulation. Course focuses on how nutraceutical regulatory affair professionals work in a company and understanding of key responsibilities and job functions. 

Above all, the nutraceutical regulatory affairs course provides in-depth understanding on the nutraceutical registration pathways in different regulatory agencies.

Course Information at a glance

  • Course Title: Advanced Certification in Nutraceutical Regulatory Affairs (ACNRA)
  • Maximum Course Duration: 1 month. Users can complete the course within a stipulated 1 month course period
  • Type of the course: Self paced Online learning. Access the course 24×7 from anywhere. 
  • Course Code: RYD-121
  • Certification: Certificate will be provided at the end of the successful completion of the course

At Royed, we also have an advanced certificate course in Food Regulatory Affairs.

In these online self-paced modules, participants will be understanding about the nutraceutical regulatory planning process in detail. Therefore, it is ideal training for those who want to handle, manage or launch nutraceutical formulation in the marketplace. Moreover, this nutraceutical course provides guidance on regulatory requirements for nutraceutical products for various regulatory bodies. Above all, nutraceutical regulatory professional must have skills on nutraceutical product dossier preparation. This course provides much needed hands-on training on regulatory writing aspects for the nutraceutical formulations. 

The course trains the candidate on nutraceutical product development, regulatory approval, compliance management process will be covered in phased manner for easy understanding. Moreover, the course covers fundamentals to advance regulatory audits which is required by nutraceutical industry. Above all, this course features nutraceutical export documentation for successfully carry out export of the nutraceutical products. 

Fundamental to advanced training on nutraceutical product commercialization

Throughout the course, participants will learn how to interpret and apply regulatory guidelines effectively to ensure nutraceutical products meet safety, quality, and efficacy standards. Practical insights into regulatory submissions, documentation requirements, and risk management strategies will be provided, preparing participants to navigate the complexities of regulatory approval processes. Here are the key topics which are covered in the course:

Fundamental section on Nutraceutical Regulatory Affairs Course

  • Overview of the Nutraceutical Industry. 
  • Introduction to advanced learning on Nutraceutical Regulatory Affairs. 
  • Classification of Foods, Dietary Supplements and Nutraceuticals. 
  • Understanding of various nutraceutical ingredients, classifications, unique selling points, positioning statements. 
  • Nutraceutical and disease management. 
  • Nutraceutical product class market dynamics. Recent updates of the nutraceutical market. What’s creating buzz in the Nutraceutical market.
  • Regulatory Agencies and Frameworks: Understanding the roles and responsibilities of regulatory agencies such as the FDA (USA), EFSA (Europe), Health Canada, and others. Exploring global regulatory frameworks and their impact on nutraceuticals. Key Regulatory Requirements for Nutraceutical Business. 
  • Development and Commercialization process of Nutraceutical. 
  • Understanding of the Nutraceutical Regulatory Cycle.   
  • Requirements of Food, Dietary Supplement Good Manufacturing Practices. All different sections and modules. Detailed understanding on food manufacturing standard development. Audit of nutraceutical plants. Data Integrity and Warning Letter handling training. Recall Management Process. 

Advanced section on Nutraceutical Regulatory Affairs Course

  • Ingredient Safety and Assessment: Principles of safety evaluation for nutraceutical ingredients, including toxicological assessments, GRAS (Generally Recognized as Safe) status, and novel ingredient approvals.
  • Labeling and Claims: Regulatory requirements for nutraceutical product labeling, including mandatory information, permissible claims (health claims, structure/function claims), and substantiation of claims through scientific evidence.
  • Food Safety Management Process. 
  • Good Manufacturing Practices (GMP): Understanding GMP requirements specific to nutraceutical manufacturing facilities to ensure product quality and consistency.
  • Regulatory Submissions and Approvals: Procedures and documentation required for regulatory submissions, including new product notifications, pre-market approvals, and post-market surveillance. Documentation for launch of a new dietary supplement product and regulatory filing in US, Europe, UK, India, Canada, Japan, GCC, African Region.  Nutraceutical product Dossier preparation – Specific Formats for Regulatory Bodies 
  • Quality Control and Assurance: Principles of quality control and assurance in nutraceutical manufacturing, including batch testing, stability testing, and quality management systems.

Advanced section on Nutraceutical Compliance and Auditing

  • Compliance and Audits: Strategies for maintaining compliance with regulatory requirements, conducting internal audits, and preparing for regulatory inspections.
  • International Regulations and Harmonization: Differences and similarities in nutraceutical regulations across different countries and regions, and efforts toward international harmonization.
  • Emerging Regulatory Issues: Current trends and emerging issues in nutraceutical regulation, such as regulation of botanicals, probiotics, and personalized nutrition products.

Who should attend this Nutraceutical Regulatory Affairs Course? 

  • Those who are in Nutraceutical Business Operation working in various departments like  regulatory affairs, product management, business development and marketing. 
  • Professionals from nutraceutical business owners, top management and middle management professionals working in nutraceutical business development, brand management, digital marketing etc. 
  • Those who want to have a clear cut understanding how to operate and manage the nutraceutical business. 
  • In fact this course is ideal for the pharmaceutical management and business professionals who want to have real life exposure on know-how of the nutraceutical industry. 
  • Fresher or beginners, Those who want to make a career in the nutraceutical industry. 

Course features

  • Orientation to job related practical aspects of the professionals working in nutraceutical regulatory and quality assurance. 
  • Simulation to real life working in the regulatory affairs department. Hence it helps to enhance the regulatory strategic decision making.
  • Advance training on food registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about food regulation and registration.

Few of the similar courses

About Nutraceutical Regulatory Affairs

Nutraceutical Regulatory Affairs involves the oversight and compliance with regulations governing nutraceutical products, which are food or food-derived substances that provide medical or health benefits, including prevention and treatment of diseases. Therefore, this field ensures that nutraceuticals meet safety, quality, and efficacy standards set by regulatory authorities such as the FDA in the United States, the EFSA in Europe or regulatory standards of other countries. Professionals in Nutraceutical Regulatory Affairs navigate a complex landscape of regulations to ensure that products are accurately labeled, supported by scientific evidence for their health claims, and manufactured under appropriate conditions. They play a critical role in product development, from initial formulation through to market approval, ensuring that consumers have access to safe and effective nutraceuticals.

Key responsibilities of Nutraceutical Regulatory Affairs Professionals

Key responsibilities include interpreting regulatory guidelines, conducting compliance assessments, preparing regulatory submissions, and maintaining ongoing compliance as regulations evolve. Nutraceutical Regulatory Affairs professionals collaborate closely with research and development teams, quality assurance, and marketing departments to navigate the regulatory framework effectively while advancing innovation in the field of nutraceuticals. Their expertise is crucial in ensuring that products not only meet regulatory requirements but also inspire consumer trust and contribute positively to public health.

What is Nutraceuticals? >> Learn more

Section 1Nutraceutical Business : Fundamental Topics on Overall Business Management
Lecture 1Nutraceutical and Disease Management Matrix
Lecture 2Dietary Supplement (DS) | Nutraceutical | NHPs | Functional Food | Phytochemicals | Multivitamin - Mineral Supplement - Differentiations, Similarities, Regulation requirement assessment 
Lecture 3Dietary Supplement Vs. Nutraceutical : Analysis of Term
Lecture 4Nutraceutical / Dietary Supplement Market Insight | Overall Market Size, dietary supplement market segmentation,  Ingredient wise market share, Dosage Form, Usage and Application Segmentation, End user outlook, distribution channel 
Lecture 5Functional Foods | Definition | Characteristics | Categories | Examples with usages
Lecture 6Functional Foods Master Classification: Understanding of various nutraceutical ingredients, classifications, unique selling points, positioning statements
Lecture 7Segmenting the Nutraceutical Market
Lecture 8Developing Nutraceutical Portfolio for the organization
Lecture 9Case Study : Developing Nutraceutical Portfolio for the organization
Lecture 10Nutraceutical Multi Segment Forecasting | Case based practical Insight 
Lecture 11Nutraceutical and Disease Management Matrix
Lecture 12Nutraceutical Ingredient Master Database
Lecture 13Key Activities for Nutraceutical Product Manufacturing | Checklist | Step by step process planning
Section 2Nutraceutical Regulations and Laws | FASSI Regulations
Lecture 14Introduction to Nutraceutical Business Management course
Lecture 15Certifications for Food Business | Understanding on various types of certification
Lecture 16Regulatory Affairs functions in food business 
Lecture 17New Food Product Development | Food Commercialization Process | NPD and Regulatory Activities 
Lecture 18Introduction to Food Hygiene and Safety
Lecture 19Food | Definition| Classification| Unsafe and Hazardous foods 
Lecture 20Principle of Safe Food Preparation 
Lecture 21Food Control | Important Principles | Component of food control system | Responsibility for food controls 
Lecture 22Food Law | Overview of EU regulations 
Lecture 23Regulatory Agencies of different countries 
Lecture 24Dietary Supplements and Regulations | Premarket activities | labeling requirements | Claims, Approval requirements | Manufacturing Requirements 
Lecture 25Introduction to Nutraceutical | Functional Food | Dietary Supplement | Health Food | Regulation and Approval Process
Lecture 26Nutraceutical Registration in India | FASSI guidelines | Process of FASSI licensing | FAQs 
Lecture 27FASSI Nutraceutical Registration Pathway | Step By Step Planning  
Lecture 28FASSI Novel Food Approval Pathways | Step By Step Planning | Key considerations for novel food designation
Lecture 29FASSI Nutraceutical Class Designation | Practical Examples with reasoning
Section 3GMP Requirements for Nutraceutical Plants
Lecture 30Premises & Plant Layout Designing
Lecture 31Sanitation and Hygiene
Lecture 32Equipment Module
Lecture 33Production Module
Lecture 34Documentation
Lecture 35Quality Control
Lecture 36Product Complaint
Lecture 37Storage Module
Section 4Quality Management System of Nutraceutical Plant
Lecture 38Food Product - Risk Management - Introduction 
Lecture 39ISO Certification and audits
Lecture 40BRCGS
Lecture 41ISO 22000 
Lecture 42FSSC 22000
Lecture 43PrimusGFS
Lecture 44NON GMO
Lecture 45The Plant-Based Certification Program - PBS
Lecture 46HALAL Certifications
Lecture 47Other Feed Safety Certifications
Lecture 48Certification for Nutraceutical, Food, Dietary Supplement Plants
Section 5Registration and Regulation of Food Supplement | Dietary Supplement | Nutraceutical Regulation
Lecture 49Dietary Supplement Products & Ingredients | New Dietary Ingredients (NDIs) 
Lecture 50NDIs Premarket notification 
Lecture 51Case Studies - NDI designation Process
Lecture 52NDI – Notification Requirements and Adulteration Standard
Lecture 53Developing Safety Profile for New Dietary Ingredient | Dietary Supplement Safety Narratives | common error about margin of safety in NDI notifications
Lecture 54NOEL | NOAEL 
Lecture 55Safety Factor Determination based on Animal Toxicity Study 
Lecture 56Margin of Safety | Safety factor | Safety Discussion in NDI notification
Lecture 57EDI | ADI 
Lecture 58Case Study: NDI notification and   generally recognized as safe (GRAS)
Lecture 59NDIN Safety Information Package | Documentation | Different Sections | Templates 
Lecture 6075 Day Premarket NDIN Submission List
Lecture 61NDIN Case Studies and Discussion 
Lecture 62NDIN Master File
Section 6Documentation for launch of a new food product and regulatory filing
Lecture 63Food Dossier
Lecture 64Novel Food Approval Process in India
Lecture 65EU Food Authorization
Lecture 66Novel Food
Lecture 67Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods
Section 7Nutraceutical Labeling : Understanding key terminologies
Lecture 68Introduction to Food Labeling 
Lecture 69FDA Labeling Requirements
Lecture 70Label claim for conventional food and dietary supplement
Lecture 71Food Label | PDP | Information Panel designing | Compliance from Regulatory Perspective
Lecture 72Net Quantity of content statement 
Lecture 73Expiration Dating | Best Before | Use By | Sell By Dates
Lecture 74Gluten Free Labeling of Foods
Lecture 75Traffic Light Labels | How to design | Reference Intake 
Lecture 76Daily Value (DV) | % Daily Value (% DV)
Section 8Food Shelf Life Stability Testing
Lecture 77Nutraceutical Shelf Life Stability Testing | Stability Studies | Expiration Dating
Lecture 78Stability Study of Processed Food  
Lecture 79Health Supplement - Stability Study | Study Design - Batch Selection | Testing Frequency | Reduced Batches | Storage Condition | Container Closure System 
Lecture 80Climate Zone
Lecture 81Stability Zone Finder
Lecture 82Accelerated and intermediate testing conditions
Lecture 83Long Term Stability Study
Lecture 84Stability Data Sheet
Lecture 85Testing Frequency
Lecture 86Bracketing
Lecture 87Matrixing
Section 9Export and International Business of Nutraceuticals
Lecture 88Introduction of Export Documentation | Understanding of important terminologies
Lecture 89Proforma Invoice - Detailed understanding how to prepare Proforma Invoice
Lecture 90Export Contract | Importance | Considerations | Things to include in Export Contract
Lecture 91Commercial Invoice | Importance | Differences with Proforma Invoice 
Lecture 92Custom House Agent | Role, Responsibilities, How they work | Freight Forwarder - Difference with CHA | Case Study
Lecture 93Letter of Credit | How it works | Different types of LC | LC terms and conditions | Sight LC | Case Studies
Lecture 94Bank Guarantee (BG) | How BG works | Differences between BG and LC | Applicability of BG
Lecture 95LC Discounting | How it works | How to calculate the LC discounting
Lecture 96Packing List | Importance | Things to include in packing list
Lecture 97Incoterms | 2020 Incoterms | Practical understanding on different types of Incoterms | Choosing the right incoterm
Lecture 98Logical selection of Incoterms | Landing in right incoterms for your business
Lecture 99Pre-shipment Certificate | COO |CVO| Fumigation Certificate | Preshipment Inspection Certificate | Certificate of Health
Lecture 100Transport Documents | Bill of Lading | Different Types of Bill of Lading | Airway Bill
Lecture 101Airfreight calculation | Gross Weight | Tare Weight | New Weight | Volumetric Calculation | Freight rate calculation
Section 10Inspection and Audit of Nutraceutical Manufacturing Plants
Lecture 102Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 103Data Integrity
Lecture 104Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity
Lecture 105RTQs | Response to Queries | How to handle Regulatory Queries  
Section 11Nutraceutical Marketing and Brand Management
Lecture 106Nutraceutical Brand Name Selection | Searching Availability
Lecture 107Registering Nutraceutical Brand Name and Protection
Lecture 108Nutraceutical Brand Logo Development
Lecture 109Preparing Nutraceutical Brand Marketing Plan Preparation
Lecture 110Launching Nutraceutical brand in market
Lecture 111Nutraceutical Brand Visual Aid Preparation
Section 12Nutraceutical Brand Marketing Plan Preparation
Lecture 112Nutraceutical Marketing Plan : Various sections | Understanding key contents
Lecture 113Sample Nutraceutical Marketing Plan
Lecture 114Launch plan of nutraceutical brand
Section 13Nutraceutical Sales Management
Lecture 115Types of Nutraceutical Sales
Lecture 116Online Sales Activities
Lecture 117Offline Sales Activities
Section 14Nutraceutical Digital Marketing : Hands on training
Lecture 118Introduction to Digital Marketing 
Lecture 119Inbound and outbound marketing in pharma | Types of inbound and outbound marketing 
Lecture 120Digital Media Marketing Macro-Environment Analysis | Mapping of online market place | Internet marketing conversion process | Conversion Process Digital VS. Traditional | Publisher revenue model | Affiliate revenue model
Lecture 121Digital Media Marketing Micro - Environment Analysis | Web server | Web browser | http vs. https - Significance and hands on understanding | Privacy and ethical issues in internet marketing
Lecture 122Digital marketing strategy development | Planning process | E-Marketing Plan | Planning for MNC Vs. Start Up | Strategic Outcome measurement
Lecture 123Relationship marketing using digital platform | CRM | Concept of permission marketing | User Satisfaction and loyalty management | Feedback mechanism
Lecture 124Campaign planning for digital media | Goal setting | Tracking | Campaign insight | Segmentation and targeting | Message Development | Media Mix Selection | Media scheduling | Practical understanding to campaign performance matrics | CPC | CPA | PPC | ROI | CPS
Lecture 125Basics of Advertising : Introduction
Lecture 126The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation
Lecture 127The Advertising agency Selection Process with Case Based Learning on Creative Brief Preparation
Lecture 128Brand Recall | Brand Recognition |Top of mind - How to calculate brand recall value?
Lecture 129Advertising Planning - ATL, BTL, TTL activities
Lecture 130Search Engine Optimization | Search Engine Marketing | Social Media Marketing
Lecture 131Web Analytics - Tool and Implementation 
Lecture 132Web Host - Check the hosting details 
Lecture 133Page Speed- importance and practical understanding | Check the web speed 
Lecture 134Keyword | Keyword Planning for SEO and SEM | Keyword Planner
Lecture 135Mobile Responsive | Tracking the Site 
Lecture 136Google Ad - Practical Training on Campaign Development and Execution
Section 15PR Activity Campaign
Lecture 137Public Relation - PR firm | PR Campaign | Press Release | Technical understanding of press release writing | Digital Press Release
Lecture 138Press release partners