- LATIN: Peru, Chile, Jamaica, Panama
- South East Asia: Philippines, Malaysia, Cambodia &, Myanma
- Asia: Srilanka, Nepal , Maldives , Afghanistan
- Africa: Zimbabwe, Kenya, Tanzania, Zambia, Nigeria, Ghana, Uganda, Rwanda, Ethiopia, Benin, Burkina Faso, Ivory Coast, Mali, Senegal
- CIS: Russian Federation, Ukraine, Moldova ,Kazakhistan & Uzbekistan.
Our Regulatory Affairs team is highly competent with strategic and tactical experience and works in collaboration with different stakeholders in:
- Designing an appropriate regulatory approach for product development
- Support in generating Right First Time (RFT) documentation for faster approvals & early market launch
- Lifecycle management of registered products & their post-marketing surveillance
- Ensuring regulatory inspections & their maintenance
Till date, 580+ dossiers have been filed in CTD & regional formats for different category of the products in emerging markets across the globe, out of which 350+ approvals have been recieved. The team ensures the lifecycle management of these registered products and their post-marketing surveillance. It also works in tandem with the various Health Ministries to facilitate the regulatory inspections of our sites prior for product registration.
In a nutshell, our regulatory affairs team acts as a communication channel and negotiate with Health Ministries during various stages of product registration, as well as a guiding department to stakeholders during commercials.