Blog & Article
- 18th April 2024
Fact Flyers related to Regulatory Affairs and CMC
Fact Flyer
As an outsourcing and consulting services company, PharmaLex is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. These flexible solutions range from an integrated package of services to adapted adhoc regulatory and technical support. Our goal is to explore innovative approaches and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.
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.