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


We are always available for a conversation.


Communication Preference

Communication Preference