Regulatory Affairs Training Courses

• Trainer Expertise — Our instructors are regulatory affairs leaders with experience spanning small biotech start-ups, global pharmaceutical companies, CROs, and health authorities such as EMA and FDA. They bring first-hand knowledge of dossier preparation, submissions, and regulatory strategy.

• Practical Focus — Case studies, group exercises, and real-world regulatory scenarios ensure you can directly apply what you learn to your organisation’s compliance and submission activities.
• Global Regulatory Coverage — Courses cover all major frameworks, including EMA, FDA, MHRA/UK, ICH guidelines, and international regulatory harmonisation, giving you a global perspective on pharmaceutical regulation.
• Post-Learning Support — Access reinforcement materials, comprehensive reference guides, and continuous updates so you stay current with evolving regulations and can embed learning into daily practice.
• Flexible Delivery Formats — Select from live online, hybrid, classroom, or on-demand formats to suit individual learners and team requirements.

In our regulatory portfolio topics include:

• Introduction to medicines regulation (EU, UK, US)
• Marketing Authorisation Applications (MAA) & global submission strategies
• Common Technical Document (CTD/eCTD) structure & content
• Variations, lifecycle management & regulatory maintenance
• Labelling, product information & regulatory requirements
• Interactions with agencies (EMA, FDA, MHRA) & health authority procedures
• ICH guidelines, global harmonisation & regional differences
• Regulatory strategy for generics, biologics & advanced therapies

Our training courses are ideal for:

• Regulatory affairs professionals at all levels (beginners to advanced)
• CMC, QA and development staff needing regulatory awareness
• Project managers and cross-functional teams supporting submissions
• Biotech and pharma companies preparing for global market entry

Global Regulatory Affairs Training for Pharmaceuticals

Navigating pharmaceutical regulations requires up-to-date knowledge of evolving requirements across multiple regions. Educo’s training courses provide expert insight into EMA, FDA, MHRA and ICH frameworks, helping you manage submissions, maintain compliance, and anticipate changes.

Dossier Preparation & CTD/eCTD

Our courses explain the Common Technical Document (CTD/eCTD) structure, dossier compilation, and strategies for successful marketing authorisation applications. Learn how to prepare high-quality submissions that meet agency expectations.

Variations, Lifecycle & Maintenance

Post-approval regulatory work is as critical as the initial submission. We cover variations, renewals, extensions, labelling changes, and lifecycle management, ensuring you can maintain compliance and respond effectively to regulatory updates.

Regulatory Strategy Across Markets

Whether working on small molecules, biologics, or advanced therapies, our courses help you develop a global regulatory strategy. Understand how regional differences affect submissions and how harmonisation (ICH) is shaping the future of pharmaceutical regulation.