Regulatory Labeling

Regulatory Labeling

As a critical aspect of product lifecycle management, labeling is one of the complex processes of life sciences’ Regulatory environment. Due to constantly evolving Regulatory requirements, organizations must ensure that the product information related to manufacturing, safety and efficacy, mentioned on the labels is controlled by maintaining a central or core reference product information.

Labeling is a highly regulated and complex process that can include multiple documents targeted at diverse audiences such as patients, physicians and pharmacists. A label is very specific and precise in its content, especially with respect to safety data and adverse effects. Furthermore, the label needs to comply with country-specific regulations governing the product.

Mabh team is experienced in end-to-end labeling operations management and technology from initiation of the labeling request form/ change request for labeling to implementation of the same.

We have Expert Pharma Labeling Affairs professional for scientific review, compilation and finalization of submission documents.

Mabh offers end-to-end labeling services for global and regional labeling management for all type of labeling submissions which include original ANDA labeling, labeling amendments or labeling supplements.

Our expertise in global label development includes:

  • Create and review RLD Word Document
  • Create and review Redline (RLD word document modified to have generic information)
  • Create and review Package Insert
  • Create and review Medication Guide/ Patient Information/Instruction for Use
  • Create and review labeling comparisons for Package Insert
  • Create and review SPL
  • Create and review Container/Carton Labeling
  • Create and review labeling comparisons for Container Carton label

  • Our labeling experts can manage and oversee all labeling activities for clients:

  • Continuously interacting with regulatory guidance.
  • Monitoring of RLD updates
  • Taking input from received deficiency and implementing same for next product to achieve first cycle approval.