Our team of dedicated professionals are at your disposal for continuous support on all stages of our CDMO partnership: from defining an unique, customized product formulation to regulatory submission and route-to-market strategy.
Striving for a high service level, accurate documentation and timely delivery, we have succeeded in becoming a valuable partner for worldwide prominent companies. Our products are marketed or are being registered in 27 countries throughout Europe, North and South America, Middle East and Asia.
We have developed a wide expertise in CDMO services as the demand increased fast both on local and on international markets.
How does a trustworthy journey from idea to practice look like?
Scale-up manufacturing and development optimization
Flexibility in dealing with unpredictable, ever-changing priorities
Increased speed to market through a well-defined workflow, scalable processes to eliminate downtimes
Our turnkey process helps you launch and grow successful products through: pilot and full-scale manufacturing, experience-based solutions, fully integrated resources and clockwork delivery.
Microbiological, biochemical and physico-chemical analytical methods are used both for testing during processing and for batch release. We provide testing of all raw materials, processing materials, packaging, finished products and stability samples.
The Quality Control Department is equipped according to GMP standards, the tests being performed and validated according to the European Pharmacopoeia.
We support the development, optimization and validation of new analytical methods and stability studies in line with ICH guidelines.
We intend to support and complete the R&D (pilot station dedicated to each production line) activity with bioequivalence studies for the launch of effective generic drugs on the local and global market – an essential element of the current business strategy. We provide to our external partners, bioequivalence studies, in accordance with the authorities' regulations, at competitive prices.
The bioequivalence clinical studies center is organized as follows: the clinical unit, the bioanalytical laboratory, pharmacokinetics and statistics.
We own an independent clinical unit, with a well-prepared medical staff and with a large expertise, making sure that the clinical studies are led in a very well controlled environment, complying with the regulations of protection and security of the subjects.
The Clinical Unit has a capacity of 26 beds (5 saloons, each with its own bathroom), information room, medical cabinets, emergency room, rooms with samples, meal room/recreation, all of them being equipped according to legislation requirements.
The Bioanalytical Laboratory is equipped with the latest medical equipment. In order to observe the flows of materials, biological samples, we have dedicated areas for primary processing, regular processing, analysis, sample storage.
The bioanalytical department and the experience of our laboratory staff, enable the development and validation of the bioanalytical methods, as well as the analysis of the biological samples that are resulted from the requested clinical trials.
Pharmacokinetic and statistical evaluation of the results is carried out by experts, using a globally approved software.
Our team provides extended pharmacokinetic and statistical support in clinical trials.
