Parexel ® Regulatory Outsourcing Services (PROS)

Dedicated care for regulatory resources.

When it comes to resources, a lot of time and energy is spent maintaining products already on the market. It’s important work that helps keep sales where they ought to be. Because of this, outsourcing regulatory services has become a valuable way to reduce costs and improve processes, so clinical development organizations can focus on continuing to create the therapies the world needs.

Regulatory Outsourcing Services

To help you develop outsourcing solutions for maintaining your therapy throughout its regulatory lifecycle, we combine technology with a deep understanding of your needs. We then bring considered global and local understanding of regulatory requirements for a flexible outsourcing model. We work behind the scenes to give you predictable year-over-year savings, so you can focus on doing what you do best.

Pre- and post-approval

When it comes down to it, we can help with a range of big-picture and tactical pre- and post-approval activities. From compilation, publishing, and dispatching of regulatory dossiers, to authoring of product variations and annual reports we can lend a hand with a variety of lifecycle maintenance tasks. Then, we’re able to provide functional outsourcing and full regulatory portfolio management of established brands.

In addition, we are a leader in the regulatory support for Mergers and Acquisitions, and our team have supported some of the largest asset transfer deals in recent years,  providing unparalleled expertise and experience.

Our Regulatory Outsourcing Services Include:
  • Regulatory Operations
    • Submission management
    • Regulatory dossier compilation, publishing and dispatch
    • Investigational filings and lifecycle maintenance
    • Market authorization filings and lifecycle maintenance
    • Post-approval lifecycle maintenance
    • Report compilation and publishing
    • eCTD import or baseline services
    • RIM data services
  •  Regulatory Affairs
    • Portfolio management, global and local RA/RO
    • Product license transfers
    • Functional outsourcing (CMC, labelling/artwork)
    • Staff augmentation

We are always available for a conversation.

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