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 increase in submissions and getting timely approvals is definitely a complicated act this being said turning around a variety of post approval submissions related to a portfolio of mature products has become quite tedious as any changes pertaining to Chemical composition, Manufacturing process, transfer of manufacturing sites, Labels and many other changes have to be reported to Health Authorities, based on the Regulations prevailing in the respective Markets
Maintenance is required:
- Annual Updates
- Packaging & Labeling Changes triggered for Marketing / Safety reasons (eg. New Packaging, Claims on Pack etc.)
MakroCare’s Regulatory Center of Excellence (RACoE) can offer, efficiency, reusability and significant Cost Benefits associated with Renewals, Variations / Amendments Submission & Dossier Preparation activities.
MakroCare’s RACoE is one of the pioneers in offering 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