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Development for NCEs

We offer a broad range of services for NCE development. The formulation could be a simple API in capsule or may require a drug delivery system to be developed. PSR has necessary expertise and access to advanced technologies to develop the formulation and also, through the use of targeted analytics, supply the client with the…

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Associate services

PSR has network of business associates that complements our provided services In order to facilitate client’s efficiency and productivity PSR can identify and work with its partners to provide following complementary services to you product development needs: API development BA/BE studies Contract manufacturing

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Technology transfer

PSR has capabilities and experts to allow the performance of technology transfer tasks to various global manufacturing sites for the purposes of scale up and commercializing various products forms. PSR is capable of providing seamless transfer of technology of developed products and implementation all the necessary control steps. With the use of systematic protocol based…

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Formulation Development

At PSR our team of experts starts the development process by an extensive patent landscape followed by Quality-By-Design (QbD) tools throughout all stages of development process. Design of Experiments (DOE) along with risk assessment strategies i.e. FMEA allows us to design trial strategies for experimentation purposes. Using this developmental approach allows us to meet our…

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Pre-Formulation Services

Pre-formulation activities are one of the most crucial areas of the product development process.  These activities determine which process and delivery methods will provide the most stable form of the drug.  Our scientists evaluate the chemical and physical properties of the target molecule, which provides essential information on the drug’s stability. At PSR we exercise…

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Stability Studies

At PSR we have a dedicated group of qualified personnel to conduct stability studies of drug products and substances in compliance with ICH guidelines. We have reach-in stability chambers including refrigerated and freeze thaw conditions as well as photo stability and an option to scale up depending on a clients future requirements. We offer Stability…

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Analytical development and validation

PSR’s analytical team offers a range of standalone services and also supports our formulation development activities. The analytical teams are integrated with pre-formulation, product development and quality assurance teams to ensure effective and accelerated product development. Our teams experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities. PSR’s analytical…

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