Our Regulatory Affairs Coaching
At Resolve Medicode, our regulatory affairs course is designed to equip students and professionals with the skills and knowledge required navigate the complex world of regulatory compliance in the pharmaceutical, biotechnology and medical device industries.
Our regulatory affairs training program covers the essential regulatory frameworks and guidelines followed globally including those from FDA, EMA, ICH and other key regulatory bodies. We support with theoretical and practical knowledge, real world case scenarios, will help our candidates will gain deep understanding of the process involved in the development, approval and post marketing surveillance of healthcare products. We not only focus on the regulations and guidelines but also help candidates to understand how to interpret and apply rules effectively in real world scenarios.
Who can enroll
- Students who are looking for a skillset course in pharma industry with certification
- Graduates from Pharmacy, Biotechnology and Life Science background.
- Working professionals seeking to transition into regulatory affairs.
Our Course Modules
Introduction to Regulatory Affairs
Overview of the Regulatory Environment
Importance and Role of Regulatory Affairs in Pharma and Biotech
Regulatory Bodies: FDA (USA), EMA (Europe), CDSCO (India), TGA (Australia), etc.
Drug Development and Approval Process
Preclinical and Clinical Trial Phases (I-IV)
IND, NDA, ANDA, BLA – Application Procedures
Clinical Trial Protocol and Good Clinical Practices (GCP)
Regulatory Documentation and Submission
Common Technical Document (CTD/eCTD)
Dossier Preparation for Global Submissions
Regulatory Writing: Investigator Brochure, Package Inserts, Labels
Global Regulatory Guidelines
ICH Guidelines (Q, S, E, M series)
FDA Guidelines and CFR
EMA and WHO Requirements
Regulatory for Biologics, Vaccines & Medical Devices
Regulatory Pathways for Biologics
Device Classification and Approval (510(k), PMA)
Combination Products
Post-Approval and Lifecycle Management
Pharmacovigilance and Risk Management Plans
Post-Marketing Surveillance
Product Labeling Changes, Renewals & Variations
Regulatory Compliance and Quality Assurance
GMP, GLP, GDP Overview
Inspection Readiness and Audit Handling
CAPA and Change Control
Regional Regulatory Affairs
US FDA Submissions and Interactions
EMA & European Regulatory Requirements
India (CDSCO), ASEAN, Japan (PMDA), and China (NMPA)
Ethics, Legal and Professional Aspects
Regulatory Ethics
Intellectual Property and Patent Basics
Communication and Liaison with Regulatory Authorities
Project Work / Case Studies
Real-world Regulatory Case Studies
Simulated Regulatory Dossier Submission
Why learn with us?
Industry Relevant Curriculum: Our course is designed in collaboration with our experts who understand the current regulatory landscape and support with practical knowledge aligned with real world industry standards and global regulatory bodies.
Experienced Trainer: Professionals with years of experience in regulatory affairs and compliance. Their insights go beyond textbooks to include case studies and current regulatory challenges.
Flexible Learning and Duration: Whether your working professional or recent graduate, we offer flexible schedules which allow you to learn at your own pace without compromising the quality of learning. We offer structured 45days regulatory affairs course duration that provides through guidance and industry focused coaching.
Hands on Training: We offer hands on experience that prepares you for real world challengers in the pharmaceutical sector and support regulatory affairs study materials for candidates.
Certification: Receive your recognized certification upon course completion and gain career guidance.
Placement Support: advance your career with our dedicated placement support to guide you with job openings and career development in regulatory affairs.
