Blog & Article
- 20th November 2025
Fact Flyers related to Post-Approval Maintenance
Fact Flyer
PharmaLex’s Post-Launch Outsourcing services deliver cost-effective regulatory lifecycle maintenance of established products – from full portfolio to country-based outsourcing. Growing regulatory complexity and mounting cost pressures in today’s hyper-competitive global market mean companies can struggle to sustain post-launch product revenue streams. Increasingly, organizations of all sizes are strategically outsourcing the regulatory management of established product portfolios to stay competitive, flexible and innovative
Fact Flyer
PharmaLex offers full lifecycle management for the submission process with flexible options for report-level publishing, compilation of major applications (IND, NDA, BLA) and lifecycle maintenance. Our regulatory affairs professionals are experienced in an array of electronic formats, including electronic Common Technical Documents (eCTD), and Structured Product Labeling (SPL).
Fact Flyer
Meetings with the leadership and review staff of the US Food and Drug Administration (FDA) are one of the most important resources available to sponsors seeking agency approval in the US. PharmaLex recommends holding face-to-face and teleconference meetings with FDA throughout the product development timeline.
Fact Flyer
Our CMC group provides regulatory guidance in setting specifications, method development and validation of documentation. We can help you build a positive relationship with…
Fact Flyer
Implementing a sustainable approach to the CMC compliance process. CMC compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors.