Solutions

Solutions

Regulatory Outsourcing Services

Optimizing Performance and Pipeline Value

Life sciences companies can expend up to two-thirds of their regulatory resources on maintaining products that have already been approved and are on the market. These maintenance activities provide little competitive advantage but are critically important to maintain sales.

As a result, outsourcing has become a key competitive strategy in the life sciences industry, enabling clients to focus their expertise on core competencies and innovation while moving to variable cost models via a more agile workforce. By applying multidisciplinary expertise both internally and externally where it is needed most, regulatory outsourcing can reduce costs, improve processes and accelerate approvals.

PAREXEL Regulatory Outsourcing Services leverage an operating model specifically designed to deliver a high quality, cost effective solution for lifecycle maintenance of established products. PAREXEL uniquely combines enabling technology, operational expertise and both global and local regulatory intelligence to deliver these services. The result is a scalable and flexible outsourcing model that yields predictable year-over-year savings and addresses regulatory complexities, increased workloads, and limited budgets facing the industry.

Our Regulatory Outsourcing Services include both pre-approval and post-approval activities ranging from the compilation, publishing, and dispatching of large regulatory dossiers to the authoring of routine product variations, annual reports and other product lifecycle maintenance tasks.

As your trusted partner, delivering a net positive effect on your bottom line, PAREXEL Regulatory Outsourcing Services can help you stay focused on core competencies while improving processes to expedite your product’s time-to-market. Operational and cost efficiencies, process improvement, and the ability to align available human capital to more strategic regulatory activities are just some of the key benefits.

PAREXEL Regulatory Outsourcing Services Include:

  • 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
  • Content creation and document services