Contact us on RnD@kleva.gr for further information concerning any product development.
The Research and Development department (RnD) of KLEVA Pharmaceuticals was established in 2002 for developing Kleva’s own formulations and in 2016 with main responsibility the pharmaceutical or nutraceutical research and development service for third Parties, as well as our own developments.
KLEVA Pharmaceuticals undertakes the development of a generic pharmaceutical product from the initial stages until the compilation of the pharmaceutical dossier in CTD format. These development stages include in brief:
The Research and Development department (RnD) of KLEVA Pharmaceuticals was established in 2002 for developing Kleva’s own formulations and in 2016 with main responsibility the pharmaceutical or nutraceutical research and development service for third Parties, as well as our own developments.
KLEVA Pharmaceuticals undertakes the development of a generic pharmaceutical product from the initial stages until the compilation of the pharmaceutical dossier in CTD format. These development stages include in brief:
Patent search
API sourcing
Development strategy
Quality control of the active substance
Quality control of the RLD
Formulation development
Production of lab scale batches
Production of pilot scale batches*
Stability study of lab and pilot scale batches
Process protocol and validation of pilot scale batches
Compilation of the pharmaceutical dossier in CTD format
*The stage is conducted at the manufacturing site of KLEVA under GMP conditions.
KLEVA’s Research and Development department has the flexibility to design the development of the product according to the requirements of each Client.
The department was recently transferred at their newly established facilities at the 31st km Athinon- Lamias national road at Polydendri Attikis. The laboratory is equipped with the mandatory analytical instruments of the pharmaceutical industry which include among others:
High pressure liquid chromatography
UV-VIS spectrometer
FTIR spectrometer
FTIR spectrometer
Dissolution
Osmometer
Viscometer
Optical microscope with HD camera
KLEVA’s Research and Development department has the flexibility to design the development of the product according to the requirements of each Client.
The department was recently transferred at their newly established facilities at the 31st km Athinon- Lamias national road at Polydendri Attikis. The laboratory is equipped with the mandatory analytical instruments of the pharmaceutical industry which include among others:
High pressure liquid chromatography
UV-VIS spectrometer
FTIR spectrometer
FTIR spectrometer
Dissolution
Osmometer
Viscometer
Optical microscope with HD camera
Along with the equipment for the manufacturing of laboratory scale batches, required for the test of the formulation of the product that is under development.
RnD department personnel currently consists of highly educated and experienced scientists in the field of product, analytical and formulation development; analytical validation and dossier compilation.
The department is growing rapidly in terms of equipment and personnel in order to respond to the highly increasing number of assigned projects. The graph below displays the new assigned project per year upon establishment of RnD.
Along with the equipment for the manufacturing of laboratory scale batches, required for the test of the formulation of the product that is under development.
RnD department personnel currently consists of highly educated and experienced scientists in the field of product, analytical and formulation development; analytical validation and dossier compilation.
The department is growing rapidly in terms of equipment and personnel in order to respond to the highly increasing number of assigned projects. The graph below displays the new assigned project per year upon establishment of RnD.
By this year, the RnD department of KLEVA pharmaceuticals has successfully delivered within the requested timelines; four (4) projects three (3) out of which were granted with a marketing authorization (EU and non-EU countries) while the forth is in the stage of assessment by the Authorities.
KLEVA’s RnD department is equipped and experienced for the development of the following forms:
By this year, the RnD department of KLEVA pharmaceuticals has successfully delivered within the requested timelines; four (4) projects three (3) out of which were granted with a marketing authorization (EU and non-EU countries) while the forth is in the stage of assessment by the Authorities.
KLEVA’s RnD department is equipped and experienced for the development of the following forms:
Currently developed formulations
Tablets uncoated
Modified release tablets
Film or spray sugar coated tablets
Hard gelatin capsules, containing granule powder or pellets (all sizes)
Powders
Granules
Creams
Ointments
Gels
Lotions
Syrups
Syrups with alcohol
Solutions and suspensions
Solutions for topical use
Nasal sprays
Aseptically filled/Terminally Sterilized products
Currently; the department conducts the development of the following forms for products of various therapeutic areas as is displayed on the following graph.
Currently developed formulations
Tablets uncoated
Modified release tablets
Film or spray sugar coated tablets
Hard gelatin capsules, containing granule powder or pellets (all sizes)
Powders
Granules
Creams
Ointments
Gels
Lotions
Syrups
Syrups with alcohol
Solutions and suspensions
Solutions for topical use
Nasal sprays
Aseptically filled/Terminally Sterilized products
Currently; the department conducts the development of the following forms for products of various therapeutic areas as is displayed on the following graph.