RESEARCH AND DEVELOPMENT DEPARTMENT

Kusum Healthcare Pvt. Ltd. is pharmaceutical company located at Bhiwadi (Rajasthan). Kusum Healthcare has its own dedicated pharmaceutical Research & Development facility which focuses entirely on formulation development and analytical research for oral solid dosage forms, liquid dosage forms and semisolid dosage forms. Our research and development centre has sophisticated instruments like FBP, HPLC with different types of detection capabilities and Gas chromatograph etc. The objective of our research centre is to develop NDDS products which have a multibillion dollar market worldwide which is growing at a rapid space because of less and less new drugs getting approved with ever increasing cost of new drug discovery. This space is limited and only a handful of companies globally have been able to successfully develop and launch drug delivery products at economical cost for India and for World-wide market. Research centre has mainly four divisions i.e. Formulation Development, Analytical Development, Intellectual Property Rights (IPR) and Regulatory Affairs.		  
  FORMULATION DEVELOPMENT

Formulation Development facility is well equipped for development of various solid dosage forms along with capabilities to handle semisolid and liquid dosage forms. We have a specialized team in formulation development for development of market specific products. Our development scientists possess substantial experience and expertise in the formulation development and transfer of technology of developed products. Our key focus areas are modified release formulation as well as immediate release formulations of otherwise poorly bio-available products. We have used proprietary hydrogel matrices, as well as non-polymeric release rate controllers for modified release products, and absorption enhancement processes for molecules with poor bioavailability. Our formulation development team undertakes work on new active substances, generics and reformulation of existing products. Our facility works in following areas; pre-formulation, formulation of wide variety of dosage forms, and technology transfer of developed products.
ANALYTICAL DEVELOPMENT

Analytical Development facility is well equipped with state-of-the-art equipments. We have a specialized team in place for Analytical Services to develop robust, precise & validated methods and supporting sophisticated software applications required for analytical development. Our development scientists possess substantial experience and expertise in the development, validation and transfer of analytical methods – be it a “stand-alone” method that provides a key piece of information in a project, or an integrated suite of methods for support of comprehensive development. We have fully automated high throughput quaternary Gradient HPLC systems with UV detectors and binary gradient HPLC system with PDA detectors which is a very useful detector for method development, impurity profiling and forced degradation of drug products. 		 
  REGULATORY AFFAIRS

Regulatory affairs department in a pharmaceutical company ensures that organization complies with all of the regulations and laws pertaining to drug research, development and manufacturing as per concerned countries. This department works with federal, state and local regulatory agencies on issues affecting drug research and development. Pharmaceutical Regulatory Affairs is dedicated to ensuring the safety of a company’s pharmaceutical products. The Pharmaceutical Regulatory Affairs department is responsible for ensuring that a company’s drug promotion is not false or misleading and that the complete picture of a drug is given to the public. The Regulatory Affair department provided the services like Preparation and/or review of regulatory submissions to FDA and / or respective regulatory Agency. The regulatory departmental staffs are well qualified in the area of pharmaceutical regulatory.
INTELLECTUAL PROPERTY RIGHTS (IPR)

As Kusum Healthcare is a generic formulation manufacturer, therefore, for development of generic products current status of patent of proposed products should be clear to avoid any indulge of law suit for existing patents. The IPR activities are outsourced by Kusum Healthcare Pvt. Ltd. from reputed organisations of different countries.