R&D-Center Services

1. Preparation of the development project

• Project analysis;
• Preparation of a specification;
• Analysis of API market (active pharmaceutical ingredients);
• Analysis of technologies.

2. Pharmaceutical development

• 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.

3. Scaling up and transfer of drug product manufacturing technologies 

• 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).

4. PreCT and CT 

• Accumulation of samples under GMP conditions;
• Incoming control of raw materials;
• Packaging, marking;
• Outgoing control of samples;
• Selection of R&D ñenters.

5. Preparation of registration dossier

• 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.

6. Contract manufacturing

• 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.

7. Analytical development

• 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.

8. Technological development

• Development of a technology;
• Rationale of the composition and manufacturing technology;
• Lab samples;
• Document production;
• Compatibility and stability studies;
• Scaling up of the process.