Whitepaper

Maintaining Regulatory compliance at all times coupled with stringent timelines is an ongoing obligation. Creation and maintenance of labels or label documents is a continual process to any MAH since they have to collect and implement all the necessary changes in the label documents for regulatory approvals and compliance. Health authorities also communicate to the MAHs on updating information via notifications/amendment notification letters. In this regard, MAHs are responsible to collect product specific updated information from various sources and update core label information for each product on a time basis. Currently, this is done with a lot of manual processes that repetitive in nature and sometimes causing people burnout. Resorting to offshoring doesn’t help much because of continuous oversight and attritions. Digitization of labels and utilizating technology solutions for end-to-end labeling operations using automation and some artificial intelligence (AI) will be the future.

Topics Covered in this Whitepaper Include:

• How Core Data Sheet is Different from a Label
• Label Data Points
• Local label Content Management
• Advantages with Digitization & Automation