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Comprehensive cocrystal screen and ongoing support for selection

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Quotient Sciences’ experienced material scientists can support your pre-formulation screening to allow selection of your drug candidate for preclinical evaluation and identification of your drug product in early clinical evaluation.

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Biophore, an established pharmaceutical company, is engaged in the development and manufacturing of niche pharmaceutical products for the generic industry. Biophore has emerged as a trusted partner in the generic industry across US, Europe and other regulated markets.

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Uquifa offers the opportunity to manage the development activities of any drug life cycle by offering services on DMF/CTD/COS application, stability studies, process validation and analytical method validation, working standard supply or impurity

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Determination of physic-chemical properties as follows: Solubility with respect to temperature and pH, dissociation constant and partition coefficient, polymorphic evaluation and hygroscopicty.

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The comprehensive examination of the range of polymorphs which can be prepared for specific drug compounds is of profound importance for pharmaceutical companies. There are major implications in discovering all potential forms for both commercial and regulatory reasons.

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Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules.

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Polymorph screening, identification and evaluation, Comprehensive salt, hydrate or co-crystal screening studies

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Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules.

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Our services include the development & validation of analytical methods. We identify by-products and determine polymorphic product forms's broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, particle size determination etc.

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At PSR we exercise a variety of pre-formulation processes to ensure that your CMO needs are met with comprehensive analysis that is compliant to GMP and other regulatory guidelines: Polymorph Characterization Studies.

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PCI’s technical and manufacturing teams have executed countless cGMP Polymer related synthesis projects.

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Following an agreed-upon formulation strategy, we perform preformulation studies to generate data that will lead to the key valuation milestones for your drug candidate.

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Size-controlled synthesis of poly(methacrylate) random copolymers beads then used as an enzyme-immobilizing substrate.

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Butyl Methacrylate emulsion polymerization that required extensive physical manipulation to achieve a narrow particle size distribution.

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Crystallics’ unique polymorph screening methodology enhances understanding of the polymorphic behavior of drug candidates.

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Following is the list of studies that can be performed at our laboratory for polymorphism: morphology, identification of polymorph, evaluation of Polymorph for Patent, euantification of Polymorph, percentage crystallinity, equilibrium solubility of the Polymorph.

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Characterization studies for your product can be conducted prior to formulation.We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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Dalton Pharma Services is an ideal contract partner for your API Process Development. We are FDA registered and Health Canada approved, and provide integrated process development, API manufacturing and finished dose manufacturing at a single location.

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Dalton Pharma Services can perform screening of polymorphic forms for any API of interest via state of the art analysis including DSC, XRPD, FTIR and dissolution/solubility testing to determine the best polymorphic form for your product.

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GVK BIO offers preformulation services such as Polymorphic Screening