Development of formulation using scientific rationale in use of excipients to create a reproducible prototype formulation.
Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing.
Use of QbD wherever required for Product and process optimization.
Ensure proper upkeep, maintenance and calibration of the equipment.
Ensure scale up of the developed formulation works at engineering batch level.
Development of the patent non-infringing strategy for product development.
Preparation of regulatory documents for PK study and marketing approval from DCG (I).
Preparation of Pharmaceutical Development report for Quality module of CTD.
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