Literature and patent research in line with demand, starting from the evaluation of the technical feasibility, design of the research programme, cGMP (current Good Manufacturing Practice), ICH (international conference on Harmonisation), in accordance with the requirements of the European and American Pharmacopoeia the active ingredient and auxiliary materials analysis quantitative determination of impurity method development and validation studies, laboratory and pilot scale production, process validation, cleaning validation, in-use stability and compatibility studies, includes regular and accelerated stability monitoring processes and documentation.
The development of repeatable and time-cost effective activities with HPLC, UV-VIS, GC - head space and AAS instrumentation for the determination of effective substance, impurities and ancillary quantity is one of our staff's areas of expertise.
In order to implement your R & D project idea, our experts support you in the process of using domestic support/grant programs, preparing the project in a format suitable for the Related Support Program, preparing the term reports during the project and following the project.
According to our validation protocol prepared in accordance with the principles in international guidelines, we are helping our customers with our analytical method validation service in HPLC, UV-Vis, GC-head space and AAS instrumentation.
long-term stability studies and accelerated stability studies are provided for finished products and raw materials.
We provide validation service with our competent experts on the determination of process parameters, collection and evaluation of experimental data in order to provide evidence that your production processes are generating outputs that conform to the specifications you specify.
We are ready to assist our customers with the adaptation of your lab-scale product development efforts to pilot-scale process and the pilot-scale production of PP bag, PVC bag, PP bottle (flip off and screw cover) bulb and flakon packaging forms.
We help our customers to remove product residues, degradation products and cleaning agents from Process Equipment and to develop cleaning processes to prevent microbial contamination and to prove the effectiveness of the processes developed with scientific data. In this context, we provide services in developing analytical methods that can analyze the residue amount even in very low concentrations with suitable devices, determining limits for residue amount, completing the cleaning validation with worst case approach and documentation.
We provide service to our customers with our expert staff taking the reference of the guides regarding the change of finished product production place.
Your analytical methods developed in laboratories abroad or at home are transferred to your laboratory in accordance with ICH/FDA requirements.
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