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Research and Development

Grindeks has all required resources to ensure research and development of the both active pharmaceutical ingredients (API) and final dosage forms (FDF) in both – new products and generic field – in compliance with the international quality standards at affordable prices. About 60 highly qualified and competent staff members ensure research & development in the following field:

API technology development

Grindeks Active pharmaceutical ingredients technology development unit is responsible for:

  • Development of API technologies
  • Optimization of existing technologies
  • Technology transfer to manufacturing unit with a subsequent process prospective validation
  • Preparation of reference standards
  • Development part for API registration documentation.
FDF technology development

Grindeks Final dosage form technology development unit is responsible for:

  • Development of final dosage form technologies
    • tablets /capsules
    • ointments / gels / creams / shampoos
    • oral liquids
    • other technologies with partners
  • Technology transfer to manufacturing unit with a subsequent process prospective validation
  • Technological support during technology transfers on Grindeks production facility
  • Development part for drug registration documentation.
Standardisation

Grindeks Standardisation unit is responsible for:

    • Development and standardisation of analytical methods
    • Development of Quality Specifications
    • Registration documentation development according follwoing standards:
      • EU
      • USA
      • Australia
      • Canada
      • Russia
      • CIS countries
      • others
    • In-licensing and out-licensing support
Pre-clinical studies

Research activities of Grindeks are mainly focused towards the development of:

  • cardiovascular drugs;
  • neurological drugs;
  • anti-cancer drugs;
  • antiviral drugs.

Planning and organisation of biomedical pre-clinical trials are performed in the field of the development of new products. In cooperation with the leading scientific research institutions from Latvia and abroad active work is carried out in the development of several new medications.

Clinical studies, including bioequivalence

Clinical trials are research studies which try to answer scientific questions and find better ways to treat or prevent diseases. Most clinical trials follow a series of phases.

In cooperation with the leading clinicists, scientific experts and research organisations of European significance, Grindeks performs ICH/ GCP (Good clinical practise) and clinical trials of I – IV phases corresponding with the state legislation for the brand products of the company as well as bioequivalence study for generic products.

Intellectual property expertise

Grindeks Intelectual property unit is responsible for:

  • IP protection for original products and technologies
  • Patent search for new developments
  • Patent monitoring
  • Trade mark protection

Grindeks succeeded in co-operation with Latvian scientific and research organisations as well as with foreign pharmaceutical companies in fulfilment of a number of scientific projects contributing to new products research and development.

The Research and Development department is focusing all efforts on fractional product life-cycle parts and improves the process of vertical integration in the development stage starting with API development through FDF development and resulting with registration documentation.

While the majority of R&D resources is dedicated to the creation of Grindeks product portfolio, we are additionally supporting contract manufacturing service.