contract research organizations from China manufacturer

Place of Origin:

India


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Product Detail

semler research center is a contract research organization.

Preclinical Formulation Development

Analytical Development: Assay and relative substance method development based on already existing drug substance methods with partial validation to perform the preformulation studies.

Physico chemical evaluation, solubility studies: pH dependent aqueous solubility, solubility studies in alcohols and polyols solvents, solubility in co-solvents and surfactant assisted solubility

Inherent dissolution study in various pH conditions

Salt design/screening and selection

Dissociation constant redetermination

Partition coefficient and log P determination

Polymorphism study

Particle size, surface area, bulk/tapped density determination

Stability study: Solution stability, pH depended solubility, process equipment compatibility study, filter compatibility study, solid state stability, stress stability, photo stability, accelerated stability study as per ICH guidelines

Dynamic moisture absorption study

Drug excipients interaction study in solution form

Preclinical formulation

Stability study of preclinical formulation

Closure container compatibility study

Formulation Development Services for ANDA

Complete analytical development and validation as per ICH requirement.

RLD evaluation

Drug excipient interaction study

Formulation development to match the dissolution property of RLD in OGD and multimedia dissolution.

Accelerated stability in primary pack along with RLD

Scale up-identifying the critical process parameters and process optimization.

Technology transfer

Bio-batch or exhibit batch manufacturing

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