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Regulatory & Access Resources

Browse our regulatory & access resources to find the latest articles, blogs, brochures, and videos from our experts. See the latest content below.

Parexel® Regulatory Consulting Services

Parexel’s Regulatory Consulting Services empowers you to maintain control of your pathway and stay ahead of any compliance risks. With our regulatory affairs consulting services we will support you through planning, submission, and post-submission approval. A seasoned advisor is always close by and ready to guide your molecule to market, including strategic compliance experts and former FDA, EMA and NMPA employees. Take control of your regulatory path with Parexel’s Regulatory Strategy and Development Services, staffed with over 50 former Regulators from global agencies who have developed and marketed 191 out of the top 200 drugs. Additionally, our Strategic Risk and Compliance Management Specialists will work with you to quickly resolve any issues. We’re committed to helping you get breakthrough drug therapies with our efforts to stay on top of the changing global requirements, advances in science and emerging technologies. Narrator (00:02): The first wisdom of bringing life changing drug therapies to market is that nobody does it alone. That's why it's so important to choose the right partner. One with the expertise to help you navigate a development environment defined by constant change. Keep pace with increasingly complex regulatory requirements on a global scale. Design protocols to satisfy evolving scientific expectations. Unlock the value of clinical trial data. And extend the reach of your in-house regulatory department. Parexel consulting is with you from the earliest phase of clinical development through planning, submission and post-approval support to guide your journey every step of the way no matter what your challenge is. It's all part of the connected journey that unites our human expertise, business processes, cutting edge technology and data to simplify and accelerate drug development. Looking to take more control of your regulatory path and reduce compliance risks, Parexel's regulatory strategy and development services team is staffed by former FDA, EMA and CFDA regulators who draw on their broad and deep knowledge of market requirements around the world to help you chart a steady course. While our strategic risk and compliance management specialists work with you to quickly resolve any regulatory issues. So you can keep your next discovery on the fast track. Need to manage the costs of mature products. At the same time, you stay prepared for any regulatory inspections. With Parexel regulatory partnerships, you can match the requirements of each drug in your portfolio to the skills of our experienced regulatory operations team. You pay only for the resources you need, yet you're always ready to take advantage of regulatory reforms as they happen. Parexel's clinical trial regulatory services help you streamline the submission of timely, compliant applications anywhere in the world. We've revolutionized the collection, management and sharing of clinical trial data. And whether you, Parexel or a third-party manages the clinical trial, all steps are managed by a single dedicated team to lower costs and improve efficiency. For more than 35 years, in more than 100 countries. Navigate the maze of barriers that can easily get in the way of bringing life changing drugs to market. Katie Connelly (02:47): Getting breakthrough drug therapies into the hands of patients is your mission. And no other company is more committed to helping you get there. We have over 1000 regulatory experts whose job is to stay on top of the changing global requirements, advances in science and emerging technologies. This expertise makes Parexel the best partner for you as you go along your drug development journey. Start a conversation about regulatory consulting today: https://www.parexel.com/solutions/consulting/regulatory Contact Parexel at: https://www.parexel.com/company/contact-us Listen to the Parexel Podcast: https://www.parexel.com/news-events-resources/blog/podcasts Facebook: https://www.facebook.com/parexel LinkedIn: https://www.linkedin.com/company/parexel