We navigate the ins and outs of today’s complex regulatory system so you can focus on bringing your products to life.
Regulatory compliance is not just another box that needs to be checked off in the drug development lifecycle. The truth is, without strategic regulatory compliance, no drug makes it to market—and every drug in development that doesn’t make it to market means less revenue to continue research on other promising and life-changing molecules.
We continuously monitor today’s complex and ever-changing regulatory landscape so that we can efficiently and consistently deliver quality regulatory services and submissions. With our expertise, we enable the successful progress of your molecule through development, ensuring your life-changing drugs get to the patients who need them most.Learn how regulatory affairs is shaping the future of drug development
We get it right the first time—helping you to shorten the approval timeline and get your product to market more efficiently.
Our global experts bring a deep understanding of local regulatory requirements to every project, keeping your research on time and on budget. Acting as the interface between your project team and regulatory authorities, we ensure your project plan correctly anticipates what is required to achieve product approval.
By staying ahead of all current legislation, guidelines, and other regulatory intelligence, we can advise you across all aspects of the development process. This includes:
- Consulting on study design and regulatory agency engagement/agency meetings
- Regulatory submission writing and publishing
- Chemistry, manufacturing, and controls (CMC) services
- Regulatory operations
Protecting you so you can protect your patients.
Ensuring the safety of patients is always our top priority, and our global regulatory services fully support both Integrated Drug Development and our Embedded Solutions. Clear product labeling and adverse event reporting can help ensure whether a patient is appropriate for a specific treatment and avoid patient issues.
That’s why we work hand-in-hand with our Pharmacovigilance and Patient Safety team to understand and help our sponsors comply with regulatory standards that provide drug transparency around safety and usage for patients. Many of our experts have more than 25 years of experience in labeling and can provide guidance on best practices for creating labels.Discover how our Pharmacovigilance and Patient Safety solutions help us better protect patients
We are experienced therapeutic professionals delivering expertise, effective leadership, and strategic operational services to immunology clinical…
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At PRA, we perform independent research to determine the safety and effectiveness of new drugs. We are continuously looking for volunteers who want…