R&D-Center Services
The R&D Center “NovaMedica Innotech” provides comprehensive services to pharmaceutical companies - from drug development and contract manufacturing to launch of these products on the market within the required period of time.
We have successful experience in passing audits of large Russian pharmaceutical companies.
Thanks to our professional team, we are able to launch new products into production as soon as practible.
We provide the following services for the development, registration and production of solid drug products:
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1. Preparation of the development project
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- Project analysis;
- Preparation of a specification;
- Analysis of API market (active pharmaceutical ingredients);
- Analysis of technologies.
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2. Pharmaceutical development
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- Provision of raw materials;
- Comprehensive study of raw materials, compatibility studies, stress studies;
- Stability studies;
- Development and validation of analytical methods;
- Development of regulatory and technological documentation;
- Legal protection of intellectual property.
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3. Scaling up and transfer of drug product manufacturing technologies
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- Provision of raw materials;
- Incoming control of raw materials;
- Transfer of analytical methods;
- Accumulation of pilot batches;
- Validation of processes;
- Stability studies (natural and accelerated conditions including photostability).
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4. PreCT and CT
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- Accumulation of samples under GMP conditions;
- Incoming control of raw materials;
- Packaging, marking;
- Outgoing control of samples;
- Selection of R&D ñenters.
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5. Preparation of registration dossier
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- Preparation of a set of documents in the CTD format (common technical documentation);
- Accumulation of batches for pharmaceutical expertise;
- Support during registration of drug products.
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6. Contract manufacturing
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- Transfer of methods;
- Transfer of technologies;
- Validation of technologies;
- Registration of a drug product at the site;
- Provision with raw materials, manufacturing capacities;
- Drug product manufacturing.
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7. Analytical development
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- Development of methods;
- Validation of methods;
- Transfer of methods;
- Conducting a test of comparative kinetics of dissolution of solid dosage forms;
- Analysis of components of a drug product composition;
- Development of methods for determination of organic and inorganic substances in various objects using the following methods:
- Atomic absorption spectrometry;
- UV spectrometry;
- IR spectrometry;
- Gas and high-performance liquid chromatography.
- Document production.
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8. Technological development
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- Development of a technology;
- Rationale of the composition and manufacturing technology;
- Lab samples;
- Document production;
- Compatibility and stability studies;
- Scaling up of the process.
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Learn more about what equipment is used in the R&D-Center "NovaMedica Innotech" here.
If you are interested in our services and would like to contact us, you can use the contacts of the R&D-Center or send your question using the form below.
