Development of a complete documentation package for validation and qualification processes-specifications, requirements, master plans, protocols and reports
Specialists of our company in the process of qualification of the project will develop protocols of qualification individually for each client.
We carry out all types of validation processes to document that the process performed within the established parameters, proceeds efficiently and with reproducible parameters that meet all the specified requirements for the product and its quality.
We provide consulting and legal support on all issues of the procedure, assistance in obtaining a permit for the import of samples, assistance in the formation of a dossier for filing an application for registration, assistance in the organization of testing
We provide services for periodic / regular monitoring of critical parameters of clean rooms, as well as carry out an independent audit of commissioning and FAT / SAT tests
We provide professional translation of documentation for pharmaceutical, medical, industrial, laboratory enterprises from English into English
For a long time, we have accumulated vast experience together with companies from the European Union, Russia and America standards FDA, GMP, ISO 13485
Review of your quality management system and the current status of systems, equipment and processes in accordance with the stated requirements
Our technologies are fully compiled with the Quality Management System adopted by our customers
During the work of Alex Bedusenko has proven himself a thoughtful and responsible specialist in validation of computer systems of the analytical laboratory of the enterprise. With its help, KRKA RUS laboratory has successfully passed several Russian and European GMP-audits
Our company has a need to obtain a license for the production of medical devices. Experts Referente took preparation of documents, testing and records management in healthcare service. All services provided to us were performed efficiently and those terms in which it was promised. We thank Referente for the high quality of services
In connection with the expansion of the business, we applied for the service of adaptation of professional documentation, namely: a detailed essay, routings, farmatsevticheskikh requirements, etc. into English. Referente professionals made a quality translation, our European business partners were delighted. We will definitely use Referente services in the future