Pranab Gogoi

Pranab’s overall experience of ~spans over 21 years across Labeling Artwork Lifecycle Management in the pharmaceutical and lLife sciences industryies regulatory domain. He has wWorked for Mmajor Llife sesciences Cconsulting firms and havehas catered to customers such as Novartis, GSK, and Apotex, etc. as a rRegulatory SME. He has also sSuccessfully transitioned Ppharmaceutical regulatory processes and projects, implemented related technology and established quality management including audit preparedness and SOP writing.

Blogs By Author

Manage Risks with Quality Control Process for artworks in life sciences Industry

Let’s start with a case study. A mid-sized pharmaceutical company, engaged in packaging artwork management and artwork studio services, did not deploy artwork proofreading system at the artwork studio level, though it had an electronic proofreading system in review and approval stage for the Regulatory Affairs (RA) team. Due to this structure, the approval process to finalize an artwork was long and tedious. Any error introduced by the artwork studio was picked at the review and approval stage, further adding time to the artwork approval process and increasing the number of versions.

January 11, 2022

E-Labelling: A regulatory mandate ensuring ease of business

Label and artwork management in medical device companies are still seen as an afterthought and therefore, there is not enough concentration as well as investment in this area. However, with new updates such as traceability (UDI) and e-labeling, companies are compelled to invest time and money to be compliant on the regulations required.

January 11, 2022