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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Commercial and regulatory strategy considerations for biotech
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.
Improving Drug Development & Patient Access With the Right People, Processes, and Culture
What To Consider When Mapping Your Strategy For Submitting An Application To The National Drug Administration of China
Brochure: Regulatory, Development and Commercial Expertise. Operational Excellence. One Source.
Patient Recruitment in Asia
Learn about patient recruitment strategies in Asia that will reduce the clinical trial burden, as published in Pharma Focus Asia in January 2018.