Knowledge
Basic Information
A clear business strategy is essential in drug development, especially when integrated with regulatory processes.
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A clear business strategy is essential in drug development, especially when integrated with regulatory processes.
Get an overview of EudraLex, the collection of EU pharmaceutical regulations and guidelines governing medicinal products.
Discover the European Union’s legal framework for pharmaceuticals, covering marketing authorisations, and key regulations for human and veterinary medicines.
Learn about the range of products regulated by the U.S. Food and Drug Administration (FDA), including drugs, medical devices, and food safety.
Explore the comprehensive body of European Union pharmaceutical legislation and guidelines for medicinal products."
Access the official website of Swissmedic for information on regulatory standards, approvals, and services in Switzerland.
This paper provides a comprehensive guide to designing and conducting First-in-Human (FIH) trials, covering regulatory requirements, safety monitoring, dose selection, and adaptive trial designs.
Learn about the steps EMA takes to assess medicines for marketing authorization, including data submission, safety evaluations, and risk management plans.
Explore how computers are used in FDA's New Drug Application (NDA) process, from digital submissions to data management and electronic review systems.
A concise guide on the key considerations for setting the first-in-human dose in clinical trials, including risk factors and pharmacological data.
A glossary providing definitions of key regulatory terms used by the European Medicines Agency (EMA) in documents and on its website.
A comparative overview of clinical trial requirements in the EU, UK, and North America, offering insights for sponsors on how to accelerate drug development timelines.
A clear, step-by-step guide to FDA regulatory routes for medical devices, from classification to approval — ideal for MedTech startups and regulatory professionals.
Gautam's broad network features distinguished business specialists with substantial IPO experience, notably achieving the rare feat of executing two IPOs in one month, including a successful listing on NASDAQ, readily available for consultation via phone or email.
