torsdag 10 januari 2019

Årets första HoloMonitor sale ?

Bloggen hittar en ny användare av HoloMonitor M4 i Asien. Närmare bestämt i Malaysia.
Det rör sig om en läkemedelsutvecklare vid namn Malaysian Institute of Pharmaceuticals and Nutraceuticals, förkortat IPharm.

Ur deras verksamhetsbeskrivning:
Malaysian Institute of Pharmaceuticals and Nutraceuticals (IPharm) is established in 2006.
The institutes aim to be a Biotechnology's Centers of Excellence by exploiting megadiversity of Malaysian natural resources for the development of new drugs.
IPharm therefore has a mission to conduct world-class R&D to accelerate the discovery, development and commercialization of pharmaceutical and nutraceutical products.
For years, IPharm has established its capacity by developing the infrastructure and human resource. An integrated multi-disciplinary drug discovery team and related technologies including molecular biology, medicinal chemistry synthesis, molecular modeling, automated high-throughput screening, animal pharmacology, pharmacokinetics, drug metabolism, and formulation studies have been develop during these years.
For the coming years, IPharm will take steps to position as an integrated institute for applied research and development of new pharmaceuticals and nutraceuticals.
We are now ready to roll out our operations and our approach will continue to be to work with all stakeholders and leverage the well established pharmaceutical and healthcare researches, resources and industries. We have demonstrated success and most importantly, research institutes, industry partners, the government and the community are ready and waiting for us to fill this very important role.

Ur deras instrumenteringsförteckning (klicka på List) hittar vi nedanstående text.

IPharm har nyligen tilldelats en certifiering som ger dem möjlighet att forska och utveckla läkemedel åt kommersiella drugleverantörer i Europa, USA, Japan samt övriga OECD-länder som Argentina, Brasilien, Indien mfl...

IPharm obtains OECD Good Laboratory Practice compliance certificate

IPharm is proud to be Good Laboratory Practice (GLP) compliant. The OECD GLP certificate was awarded in July 2018 by National Pharmaceutical Regulatory Agency, Ministry of Health. 
IPharm is now a GLP compliant test facility, which the test results are accepted not only in OECD countries (including European countries, Japan, Korea and USA) but also in countries which adhere to the OECD's Mutual Acceptance of Data system, i.e. Argentina, Brazil, India, Malaysia, Singapore and South Africa. 
The certification reduces duplicative testing, saves laboratory costs, promotes work-sharing by countries assessing the same data and removes a potential non-tariff trade barrier.
Malaysia government has been taking effort to promote quality, safety and efficacy in pharmaceuticals. Starting 2018, registration of New Chemical Entity (NCE), biologics, herbal products with high therapeutic claims is required to fulfil GLP requirements in non-clinical safety studies. 
IPharm's GLP compliant studies currently cover toxicology for products under category of pharmaceuticals, cosmetics, veterinary drugs and food additives. 
With the GLP certification, IPharm is capable to provide non-clinical testings that are world-class standard. IPharm will continue to provide cost effective services for companies to meet the regulatory needs for both local and export market in compliance to OECD Principles of GLP, hence the companies will be able to register and export their products globally.

Denna användare är Malaysias andra i ordningen. På PHI´s hemsida hittar vi än så länge enbart denna användare
Detta Universitet har bloggen för övrigt skrivit om våren 2017. Inlägget hittas här.
Med IPharm har alltså Malaysia nu 2 användare. 
USM som är ett utbildningsväsen (Universitet som även bedriver forskning).
Och nu IPharm som får betecknas som ett renodlat Forsknings och Utvecklingsbolag (FoU eller R&D förkortat) som riktar in sig som underleverantör till de större läkemedelsföretagen.
Vi kan alltså konstatera att den tillverkande läkemedelssektorn behöver teknik som PHI kan leverera.
                                                                 Året börjar bra.

                                                                Mvh the99

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