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  • About the company
  • Our services

    R&D services

    Development of a medicinal product,
    Design of research methods,
    Preformulation/deformulation, Stability studies

    Analytical studies

    Particle shape and size analysis,
    Chromatographic analyses,
    X-ray analyses,
    Release studies

    Technological tasks

    Mixing of dry forms,
    Mixing and homogenization of liquid and semi-solid forms,
    Granulation of powders,
    Manufacture of tablets

    GMP System

    Quality control testing of the finished product and starting materials 

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GMP system

Good Manufacturing Practice (GMP)
in Novasome R&D Centre

We have:

  • certificate of Good Manufacturing Practice
  • manufacturing authorization for quality control (physicochemical testing).

We are subject to regular inspections by the Main Pharmaceutical Inspectorate to ensure the highest quality of our work.

Permits issued by the Main Pharmaceutical Inspectorate

  • Permit for the manufacture of medicinal products and tested medicinal products with regards to physico-chemical quality control tests
  • Permit to manufacture, process, and convert intoxicants and psychotropic substances:
  • group I-N - cannabis plant
  • grupy I-P - tetrahydrocannabinols
  • grupy II-P - Δ9- tetrahydrocannabinol
  • grupy IV-P - phenobarbital
  • License to manufacture, process, convert, import, distribute of category 1 precursors - pseudoephedrine, ephedrine

Scope of work under the GMP system

  • chromatographic analyses (HPLC-DAD, HS-GC-FID, GC-MS)
  • spectrophotometric analyses (UV-VIS)
  • titration analyses (potentiometry, alkacymetry, redoximetry, complexometry)
  • water activity analysis (VSA analyser)
  • particle shape and size analysis (optical microscopy, laser diffraction, DLS)
  • disintegration time study
  • average mass test
  • sizing
  • active substance release test (type I - basket, type II - paddle)
  • pH measurement
  • density measurement
  • measurement of dynamic (cone-plate) and kinetic viscosity
  • storage of samples under long-term test conditions (25°C, 60%RH)

We have the experience of a contract manufacturer, as to the quality control testing of a drug product and the initial starting material, under the quality and contract agreement terms. We are open to further develop the scope of our activities in accordance with the Client’s needs. Our qualified staff guarantee the quality and reliability of our work, moreover our clients can expect full substantive and practical support at all stages of the project’s commissioning.

Head office

Centrum Badawczo-Rozwojowe “NOVASOME” Sp. z o.o.

Novasome R&D Centre


ul. Olsztyńska 5
51-423 Wrocław

tel. (+48) 71 325 62 42
e-mail: biuro@cbr.novasome.pl

Numer BDO: 000027336
REGON: 933042938
NIP: 8982061354
KRS: 0000225784

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The administrator of your personal data provided in the form is the Centrum Badawczo-Rozwojowe "NOVASOME" Sp. z o.o. with its registered office in Wrocław 51-423, ul. Olsztyńska 5. Your personal data will be processed for the purpose of responding to your message. Detailed information on the processing of personal data can be found at https://novasome.pl/polityka-prywatnosci/.

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