Description

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:
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.
Conducting of preclinical trials.
Works on the draft normative documents with an explanatory note.
Supervision of the operating time of the first industrial series.