1. Review of new ANDA submission for Oral, Dermal, Opthal, injectables products.
2. Evaluate & respond to ANDA deficiencies in timely manner.
3. Handling of Post approval submissions.
4. Handling annual reports for approved products.
5. Handling labeling changes to support changes in RLD labeling.
6. To provide support to PSUR activities.
7. Review & comments on product development, scale-up and commercial stage documents.
8. To handle documents review for out manufactured products.
Spectrum Talent Management is a forerunner in designing Human Resources solutions specific... to the local needs of our respected clients. Providing services to clients globally our unique implementation methodology has been developed for speedy ramp-up to cater to the ever urgent needs of the industry as well as ensuring that we apply systems, measures and best practice processes in order to meet the demanding SLAs set by our clients. Read full description