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A Medical Device is any instrument, apparatus, appliance, software, material or other article intended to be used for a medical purpose and must be proven as safe and effective. …more
Ensuring every batch of life saving drug or vaccine is free from microorganisms or contamination is the responsibility of every pharmaceutical manufacturer and the expectation of every patient . …more
Biologic molecules differ from SMDs with regard to size, complexity and processing. Ensuring adequate controls of bioburden and endotoxin limits are critical to ensuring patient safety. …more
Cosmetics, personal care and cleaning products need to be effective yet dermatologically and environmentally harmless. …more
Helvic is an independent contract testing laboratory that has been providing microbiology analysis to the pharma sector since 2010.
Helvic is a pharmaceutical microbiological testing laboratory with a difference. Our passion is to offer industry leading Quality and Customer Service coupled with competitive prices.
We are committed to being best in the industry. Contact us to see how we can drive down your costs while offering market leading quality and service.
Analyst GMP Certification Extension
The Israeli MoH notified Analyst Research Laboratories that it has successfully passed its latest audit and has been rewarded with an extension of its GMP certification. The Israeli Institute for Standardization and Control of Pharmaceuticals operating under the Israeli MoH, is recognized by the European Commission under the Agreement on Conformity Assessment and Acceptance of
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Tentamus Pharma Group at CPhI worldwide 2021
The Tentamus Pharma Group bundles all competences in the field of drug and medical device testing and is made up of class leading independent laboratories, providing high quality service and support to our clients worldwide. Our client base ranges from small start-up companies to multi-national corporations, encompassing a comprehensive and diverse portfolio of services to
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More time to be ready for IVDR?
About 90 % of all in vitro diagnostic (IVD) manufacturer cannot benefit from transition period laid down in Article 110 of Regulation (EU) 2017/746 (IVDR) and must be ready for IVDR in May 2022. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022. The main
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VELTIA Labs for Life Cyprus has updated its Scope of Accreditation!
“Your life’s quality, our top priority” – VELTIA Cyprus is committed to VELTIA LABS FOR LIFE’s motto and has set a clear target for 2021. The goal was to upgrade its nutritional lab and provide its clients the services of one “stop-care lab”. “After a successful 4-day-audit conducted by CYS-CYSAB (Cyprus Accreditation Body) we are
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Foundation of Tentamus Pharma & Med Deutschland GmbH
Formation of a new company out of BLS-Analytik GmbH, TentaMedix GmbH and DSIpharm Oldenburg The Tentamus Group pleased to inform you that BLS Analytik GmbH, TentaMedix GmbH and DSIpharm Oldenburg have merged as one company with immediate effect as Tentamus Pharma & Med Deutschland GmbH. The company’s headquarters are located in Bad Kissingen, Columbiastraße 14
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Laboratorio Control extends its ENAC scope in Feed, Food and Food Additives
Committed to the continuous improvement of its analytical services, Laboratorio Control extends its ENAC (National Accreditation Body) accreditation in the Food and Animal Nutrition sectors. The Molecular Biology Department of the laboratory has successfully passed the ENAC audit which focused on the evaluation of the analytical method for the detection of Salmonella spp. and
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