It’s never too early to start crafting a global regulatory submissions strategy. Early engagement with regulatory authorities can help boost success rates and shorten clinical development timelines but there are potential pitfalls to avoid as well. Read our strategies on how to maximize benefits and minimize hazards when seeking scientific advice from the European Medicines Agency (EMA) as well as how to be smart about pre-IND meetings and other early stage FDA meetings.
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Amy McKee, Vice President Regulatory Consulting Services, addresses some of the most common misconceptions about working with the FDA.
The COVID-19 pandemic has seriously impacted the US healthcare system and supportive manufacturing facilities. Some consumers and healthcare professionals are currently experiencing difficulties...
The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...
In this blog, Parexel regulatory and strategy experts tackle the question of how we can ensure that worthy innovations in the biotech pipeline make it to patients sooner.
Learn about patient recruitment strategies in Asia that will reduce the clinical trial burden, as published in Pharma Focus Asia in January 2018.