Regulatory Outsourcing

When you need a trusted partner in regulatory operations,
our team is your team.

Whether you are looking for a few regulatory specialists to scale up existing operations or a whole team of experts, we have the global infrastructure and local knowledge to meet your needs. Parexel can help you navigate complex global regulations, with a focus on compliance and continuity of supply – taking effort, uncertainty and overhead out of managing your products.

As your partner, we work side-by-side with internal regulatory teams and other functions, supporting submissions, product registration, tracking agency interactions and more. Your products are in safe hands with our specialists – including many former regulators – who are dedicated to supporting you achieve your commercial goals.

Parexel is well-known in the industry for the depth of our expertise and the strength of our customer relationships. In fact, Parexel ranked #1 as the CRO that continually exceeds expectations in regulatory operations outsourcing in a 2020 LSSG Brand Research study.

Our services include:

• Regulatory strategy
• Technical authoring
• Regulatory dossier compilation, publishing and dispatch
• Global and local market support
• Investigational submissions
• Market authorization submissions
• Post-approval submissions and lifecycle maintenance
• Staff augmentation
• Mergers and Acquisitions  
• Regulatory information management – data entry, data cleansing, data migration