Regulatory Life Cycle Management
To sustain continuous growth pharmaceutical companies have either launched newer variants in the same market or expanded into newer markets. The potential of emerging markets has changed the landscape of Pharmaceutical industry. Many companies have realigned their models and started registering their products globally.
Managing the increased load in submissions and getting timely approvals with added burden of post approval submissions related to portfolio of mature products is tedious as any changes pertaining to CMC, Manufacturing, Marketing, Labeling, CMOs and many other changes need to be informed/reported to Health Authorities.
MakroCare’s Regulatory Center of Excellence (RACoE) can offer efficiency, reusability and significant Cost Benefits associated with Renewals, Variations/Amendments, Publishing/Submission Management, Labeling (content, operations), Dossier preparation, Regulatory Data management activities.
MakroCare’s RACoE leverages Hybrid delivery models. RA functions are typically integrated & complex processes with several hand-offs and coordination with multiple stake-holders in R&D, Regulatory, Supply Chain & Commercial Operations.
MakroCare has successfully established Onsite-Offsite-based RA Operating & Delivery Models, by integrating with our customer’s global RA processes. This when combined with our Automation platform, increases efficiency significantly.