System, equipment, software, testing and analytical methods, manufacturing and cleaning processes used for Medical Devices, Drugs, Supplements and Cosmetics have a critical impact on final product quality and patient safety and therefore should-meet Qualification, Verification and Validation regulatory requirements. Activities related to Pharmaceutical and/or Medical products development, production, packaging, sterilization, storage and shipping should be in a validated state. In order to meet the long term intended use and relevant regulatory requirements, organized, well documented Qualification, Verification and Validation processes should be completed in a successful manner. A Proper Qualification/Validation process will improve system/equipment performance, process yields and will assure that the final product meets all quality and repeat ability requirements defined by the regulator. The Validation and Qualification area is being audited and inspected frequently as part of FDA/ISO/CE quality audits, as it has a direct impact on final customer and patient health. The Bio-Chem team will support you in all regulation and submission challenges in Israel and all over the world.
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“Bio-Chem escort our company for several years, mostly on GMP, Quality System inspections, Quality Control and Validations.
Project completed by Bio-Chem supported our base business regulatory requirements as well as for leading our company to cosmetics OTC products manufacturing and export to the US market.
Bio-Chem has proven high professional level, reliability and projects tasks completion in challenging time lines”Alice Cohen
Quality inspection audits manager
“Bio-Chem’s team is great to work with.They are reliable and very knowledgeable in their field. They have years of experience and are able to advise you on all Pharma and Medical Device” aspects”Stephen Shattenstein
QA/RA at AB Dental
“Bio-Chem team and Eran Yona are well rounded in providing Quality and Validation services to the Pharma and Medical industries.
In the last four years, I have been working on several projects with Eran and Bio-Chem team.
Exposed to the services in these several occasions, I can be definitive that Bio-Chem team is highly professional and highly service orientated in delivering Quality and Validation assignments”Moshe Radovitch
Cyber Security CEO at Tera-zone
“I enjoyed working with Bio-Chem and Eran Yona. They performed excellent professional work according to defined and well-written study plans, delivering on time all the required services in several pharmaceutical manufacturing and validation projects”Shimon Amselem
Chief Scientific Officer at Space Pharma SA
“Bio-Chem led us transforming to Medical Device field. Project included clean rooms, facility design, qualifications and GMP. I enjoyed their excellent professionalism and commitment. Project completed in satisfactory quality level and in a timely manner”Sagi Ofer
Quality Assurance manager Medimor Medical Ltd