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Our training programs cover a wide range of topics, from the intricacies of regulatory frameworks to the latest guidelines for drug approval processes. Participants will engage in interactive sessions led by industry experts, ensuring that they gain not just theoretical knowledge but practical insights applicable in their daily work. Whether you’re a newcomer striving to understand the basics or a seasoned professional needing to stay abreast of evolving regulations, we provide the resources and support necessary for your professional growth. Join us to enhance your skills and empower your career in regulatory affairs as we adapt to the constant changes within the pharmaceutical landscape.
Learn CTD and eCTD Dossier Preparation in Depth
A key focus of our training is on CTD (Common Technical Document) and eCTD (electronic Common Technical Document) dossier structure and preparation. We cover all five modules in detail, explaining how to compile high-quality regulatory dossiers that comply with ICH guidelines. From Module 1 regional requirements to the quality, safety, and clinical modules (Modules 2–5), you’ll gain clear, step-by-step insights into how these documents are structured, reviewed, and submitted globally. We also include hands-on training in lifecycle management, variations, and responding to health authority queries.
Regulatory Training for UK (MHRA)
Our training includes detailed guidance on the UK MHRA submission process post-Brexit, including how to prepare and submit dossiers via the MHRA portal, requirements for national applications, and considerations for Great Britain versus Northern Ireland. We help you understand how UK regulations align with and diverge from the EU system, with practical advice on new marketing authorisation applications, variations, and renewals.
Regulatory Training for Canada (Health Canada)
For professionals targeting the Canadian market, our training explains how to prepare submissions aligned with Health Canada’s specific CTD format and electronic submission gateway (CESG). You’ll learn about the submission process for NDS, ANDS, DIN applications, and post-market changes. We also highlight key differences in labelling, monograph usage, and review timelines that distinguish Canada from other ICH countries.
Regulatory Training for the United States (FDA)
We offer detailed instruction on navigating US FDA regulatory expectations, NDAs, ANDAs, and eCTD submissions via the FDA’s ESG (Electronic Submissions Gateway). Training includes tips for FDA communication, meeting requests, responding to information requests (IRs), and post-marketing requirements such as annual reports and REMS. We also discuss the FDA’s structured product labelling (SPL) format, data integrity, and use of US Pharmacopeia standards.