After a medicinal product has obtained Marketing Authority (MA,) it is authorized for commercial use. However, maintenance obligations must continue to be met in all regulated areas.

To retain Marketing Authorization, the MA holder must continually:

  • Update work to ensure the approved dossier is valid
  • Address safety surveillance issues by having pharmacovigilance systems in place
  • Implement and maintain quality management / assurance systems to deal with developments such as changes in the manufacturing of the product and relevant changes in the company’s settings
  • Respond to renewal requirements, as necessary

Challenges that accompany large product portfolios, differing global markets, evolving regulatory landscapes, and stakeholder expectations can further increase the complexity, unpredictability and intensity of the Post-approval Phase.

Changes in development and regulations require continuous updates to systems, documents and agreements. Consequently, time and resources may be strained, causing new product development to suffer.

Seamless Support

Whether you are interested in outsourcing portfolio maintenance, require support during a merger and acquisition phase, need assistance covering your pharmacovigilance obligations or in development and implementation of your QMS—our Post-approval solutions provide trusted, strategic ways, as well as hands-on support, to keep your product compliant and moving forward.

Smart Technology + Savvy Humans = Brilliant Solutions

With over 33 offices around the globe, our highly specialized network customizes optimal, region-specific solutions for the Post-approval Phase.

Emerging Smart technologies employ computerized and automated service lines, including our PharmaLex Partnerships database, to free up time and resources—so you can focus on what is important.

Discover technology that helps you:

  • Orchestrate all global activities for GxP management within a single cloud solution
  • Automate case processing and safety literature
  • Audit incoming case safety reports
  • Manage pharmacovigilant agreements
  • Transition to a fast, holistic solution for paperless compliance
  • Evaluate possibilities with the Risk Assessment Tool for Excipients (RATE)
  • Analyze GxP vendor metrics

Success Stories

Here are some specific ways we’ve supported our valued clients:

Provided a full PV outsourcing solution for a client with over 800 MAs

and a complex partner networking system. Included: set up of PV systems, establishment of quality assured framework, delivery of operational PV activities, as well as, audits and inspections.

Supplied a one-stop solution for a client with over 500 MAs

from around the world. Included: all MA transfers and subsequent maintenance activities for RA, PV and QM—globally and locally.

Let us help you ensure timely market access, robust compliance systems, and productive health authority relationships.

PharmaLex. Confidence beyond compliance.