We offer comprehensive pharmacological service in the field of pharmacology, biochemistry and analytical chemistry.
We propose appropriate study design and prepare Study Plans for preclinical and clinical studies. Results of the GLP, GCP and GMP studies are compiled in Final Reports, which are part of the Registration Dossiers to be submitted to Regulatory Authorities.
We provide full service for biological (including laboratory examinations), analytical and statistical part of the studies.
Biological parts of GLP and GCP studies
Biological part of studies are performed on target animals (cattle, horses, pigs, sheep, rabbits, dogs and poultry) and also on laboratory animals, when the study is relevant for the research and development of pharmaceutical products for veterinary use.
Analytical parts of GLP studies
LC-MS/MS or HPLC are used for the analysis of active substances in blood plasma/serum, milk and edible tissues: liver, kidney, muscle, fat, fat and skin, etc. All methods are validated in compliance with EMEA and OECD GLP guidelines.
Statistical parts of GLP and GCP studies
Statistical evaluation of results of all studies (bioavailability, bioequivalence, pharmacokinetic, residue, tolerance, etc.) is performed using EquivTest PK, Statistica 8.0 and SAS software.
- Long-term experience in the field of veterinary pharmacology
- Highly qualified and regularly trained staff
- Flexibility
- Sponsor orientation
- Balanced proportion between service and fee (service : price)
Our Competitive Advantages
The GLP system was implemented in 1993 according to national guidelines and in 1998 as per the OECD guidelines.
In 2004 the Pharmacological Service Section acting in GLP, GCP and GMP systems was founded.
Since 1998 until present almost 500 studies were conducted under GLP regulations and 11 studies were performed in compliance with GCP regulations. Our customers have included pharmaceutical companies from the EU, Croatia, Switzerland, USA, Australia and New Zealand.
Pharmacological services are performed according to current EMEA, VICH and OECD GLP and/or GMP guidelines.
Staff
All staff members are highly qualified and regularly trained in relevant SOPs, European guidelines and regulations (EMEA, VICH, OECD) and the local legislation.
QA System
All processes are under strict QA supervision.
The QA unit inspects all points of our work starting from business negotiations to the final product
- staff member training
- material inspection
- periodic calibration and validation of equipment
- contracts
- data management and reporting
- updating and checking of SOPs
- documentation management
- strict control of all critical points of studies
QA monitoring includes:
In all activities outlined above, our company intends to continue with development so as to provide all its customers with traditional security of complex and highly professional services.
