This department is the backbone and also the life force of the company. It is here that our vision and mission comes alive. Our endeavor is to make path-breaking research that can make our future healthcare easier and better. Treating people with the local medicines with effective treatments is our priority. We have a work culture that binds our human resources team from all other departments with this department.
They are also responsible for:
- Formulation development that requires stability and validation from all regulatory standards.
- Ensuring the scalability for formulation validation and match the processes requiring it.
- Sustained analytical development for all research studies.
- Providing technical expertise for contract manufacturing.
The department also handles data management, which comprises of coordination with transfers to customer and regulatory requirements. This department is accountable for making positive changes in providing solutions for futuristic healthcare. The Concord Drugs dedicates its journey to serving pharma sector with its versatile product range which emerges from its research.
Regulatory support
A regulatory affair in Concord Drugs is a crucial link between the company, its products and regulatory authorities in international as well as domestic markets. Our well experienced Regulatory team keeps track of all relevant changes in various rules, regulation and policy matters of various countries for submission of registration dossier of Finished Pharmaceutical Products in various dosage forms and Ready-To-Fill Pellets. Typical activities by our regulatory team include:
- Keeping abreast of domestic & international legislation, guidelines and practices in India as well as countries that the company is exporting to.
- Collecting, interpreting and evaluating and writing scientific data that has been researched by colleagues.
- Monitoring and setting timelines for registrations submissions, variations and renewal approvals.
- Writing clear, accessible product labels and patient information leaflets, storage, labeling and packaging requirements.
- Project managing teams of colleagues involved with the development of new products.
- Undertaking and managing regulatory inspections.
- Liaising with, and making presentations to, regulatory authorities domestic and internationally.
