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Chemical development services

Poland
Chemical development services

Analytical chemistry

Selvita also employs top class specialists in the field of physicochemical analysis and may provide a complex physicochemical characteristics of the synthesized substances. Analytical chemistry services Selvita offers for drug discovery projects include:

-  Development and transfer of analytical methods (including chiral compound analysis)

-  Impurity profile characterization

-  Dissolution profile(pharmaceutical availability)

-  Characterization and control of polymorphic form, development of a process to obtain a specific polymorphic form

-  Residual solvents analysis

-  Pharmaceutical development registration documentation preparation (CTD, ICH)

All the activities of the Analytical Laboratory are performed in accordance with the ICH recommendations and cGMP regulations. In July 2009 Analytical Laboratory was granted accreditation by the Main Pharmaceutical Inspectorate of the Republic of Poland

 

Custom synthesis

We specialize in the synthesis of compounds with complex structures, often chiral characteristics, high purity (even 98-99%) also optical. We take on difficult syntheses, time-consuming and multistep processes, under increased pressure.

-  Planning and optimization of synthetic routesof organic substances,

-  Synthesis according to the scheme provided by the customer or methods developed in our laboratory

-  Process optimization and scale-up,

-  Broad range of purification methods

-  Synthesis under high pressure (mg to 100g scale)

 

Drug form development support

Preformulation and formulation development

-  Research and description of substance pharmacokinetic and physicochemical properties

-  Dissolution research at the product development stage

-  Performing dissolution profilesin three standard media (low/medium/high pH) for drug products + analytical method validation 

-  Verification of pharmacopoeial analytical methods, their validation and transfer (especially HPLC, UV/Vis, LC-MS and GC-MS)

-   Impurity profile characterization

-   Residual solvents analysis

-   Cleaning validation

-   Pharmaceutical development registration documentation preparation (CTD, ICH)

 

Submission documentation and Drug Master File preparation

In the field of submission documentation preparation, we propose active substance manufacturer selection, validation of analytical methods, their application and the compilation of the Applicant Part DMF.

Company
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Selvita Group

Bobrzyńskiego 14
30-348 Krakow Poland
Homepage: http://www.selvita.com/