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:
- Study design and regulatory development consultancy
- Management of regulatory information
- Regulatory submission planning, management, writing and publishing
- Chemistry, manufacturing, and controls (CMC) services
- Trial disclosures and clinical trial data sharing
- Medical writing and quality control
- 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 employ a flexible service model, comprised of cross-functional team members, that provides regulatory, scientific, and medical writing, not to mention technical QC support, quality & editorial review, clinical trial disclosures & data sharing, and data transparency across the product lifecycle.
Our combined industry and CRO experience in all phases of clinical development and in all major clinical indications, allows us to provide project management services and expert consultancy at every step.
Labs and Clinics
We provide end-to-end bioanalytical support from Pre-clinical to Phase IV studies. At PRA, our laboratories are managed, staffed, and supported by…
Basics of Regulatory Strategy
Driving development of drug products from pre-IND through marketing.