The Engineering Center with its partners (SSMU, TSU laboratory) helps companies to solve any issues of pharmaceutical production
Chemistry and Pharmaceuticals
СВЯЗАТЬСЯ С НАМИ
THE ENGINEERING CHEMICAL TECHNOLOGY CENTRE
FROM THE DEVELOPMENT OF METHODS FOR SYNTHESIS, ANALYSIS OF SUBSTANCES AND FINISHED DOSAGE FORM, THEIR VALIDATION, THE DEVELOPMENT OF PRODUCTION TECHNOLOGIES, QUALITY CONTROL TO PROMOTION AND DISTRIBUTION
We offer pharmaceutical development services with an emphasis on analytical support
It is beneficial to give the process of pharmaceutical development to outsourcing
Implementing varying drug discovering projects, it is disadvantageous to seek and maintain specialists and to purchase expensive equipment. Thus, for the development of 5 drugs in parallel, usually, you need to have five chromatographs, which means 5-10 competent chemists with a fairly high salary. If there is no own R&D department, it is simply impossible to do more than 2 developments per year in parallel.
At each stage of the new drug introduction, pharmaceutical companies face challenges that can not always be met with the least financial and temporary losses.
ALL THE ISSUES OF PHARMACEUTICAL DEVELOPMENT AND PRODUCTION CAN BE EFFECTIVELY SOLVED BY GIVING ANY OF THE STAGES OF DRUG LAUNCH PREPARING TO OUTSOURCING. THIS WILL ENABLE NOT TO DELAY THE EXPECTED REVENUE FOR YEARS AND NOT TO MISS THE RIGHT MOMENT FOR THE PRODUCT TO ENTER THE MARKET
Outsourcing pharmacy services
The ECTC offers full cycle services (from "zero point" to industrial release of the product): development of methods for the synthesis or isolation of active substance from natural raw materials, purification, production support under GMP conditions, development and maintenance of all analytical and documentary parts, production of a pilot set of the substance. If necessary, in case of a new pharmaceuticals, we carry out all kinds of trials.
It functions as an integrator, provides all the services at one place: the client sets an issue, the ECTC selects necessary resources and competencies to address it. With our help, launching a drug takes up to 2 years on average. We are ready to do analytical part within two or three months.
A complete list of our pharmaceutical development and support services includes:
It functions as an integrator, provides all the services at one place: the client sets an issue, the ECTC selects necessary resources and competencies to address it. With our help, launching a drug takes up to 2 years on average. We are ready to do analytical part within two or three months.
A complete list of our pharmaceutical development and support services includes:
We are able to connect to the process of creating a new drug or releasing generics at any of the stages. Experienced specialists will adjust all the analytical part and documentary support necessary for registration in the market in a short time.
1
Chemical-analytical studies
- Training of specialists for independent work on the profile of HPLC (individual internship program).
- Study of samples of organic compounds by NMR spectroscopy (1H, 13C, DEPT, 19F, COSY, HSQC, HMQC, HMBC).
2
R&D services
- Development of methods for the analysis of substances and finished dosage form: authenticity, quantification, extraneous impurities.
- Validation of analysis methods.
- Confirmation of the structure of standard samples (main substance, impurities) by NMR spectroscopy, gas chromatography-mass spectrometry, high-performance liquid chromatography-mass spectrometry.
- Analytical support of pharmaceutical development (substances, finished dosage form).
3
Development of intermediate products and chemicals synthesis methods of pharmaceutical purity. Scaling of synthesis methods
- Development of synthesis methods of intermediates and chemicals.
- Scaling of synthesis methods of intermediates and chemicals from laboratory amount to semi-industrial and industrial.
4
Pharmaceutical Development
- Pharmaceutical development of finished dosage form.
- Search for suppliers and raw materials order.
- Development of production technology for the drug (ampoule solution, vials solution, lyophilizate in vials, tablets, coated tablets, hard gelatin capsules, cream, gel, suppositories).
- Development of analysis methods:
— review of scientific literature (including Scopus, WoS, etc.) on impurities, methods of drug analysis;
— development of analysis methods;
— identification of impurities in samples of the drug (by impurity standards);
— preliminary assessment of selectivity, linearity, precision, correctness, development and grounding of validation criteria;
— reproduction of techniques on the client's site;
— analytical validation;
— transfer of techniques to the client's site.
— development of analysis methods;
— identification of impurities in samples of the drug (by impurity standards);
— preliminary assessment of selectivity, linearity, precision, correctness, development and grounding of validation criteria;
— reproduction of techniques on the client's site;
— analytical validation;
— transfer of techniques to the client's site.
- Conducting of preclinical trials.
- Works on the draft normative documents with an explanatory note.
- Supervision of the operating time of the first industrial series.
We are looking forward to collaboration!
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