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Regulatory Affairs
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1-15 of 3249 results
SHL to Speak and Exhibit at the Prefilled Syringe Seminar 2015 Tokyo
SHL will be attending and exhibiting at the upcoming Guide for Prefilled Syringe Seminar 2015 in Tokyo, Japan, where Executive Director of Business Development Thomas Schönknecht has been invited to speak on the topic of "Insight Into the Changing World of Auto Injectors: Trends, Partnerships and Key Learnings."
Regulatory Affairs > Press Releases
CanTx gets FDA orphan drug designation for Cantrixil to treat ovarian cancer
By PBR Staff Writer
CanTx, the Novogen-Yale joint venture, has received orphan drug designation from the US Food and Drug Administration (FDA) for its chemotherapy candidate drug, Cantrixil, to treat ovarian cancer.
Regulatory Affairs > News
CymaBay gets FDA orphan drug status for MBX-8025 to treat hypertriglyceridemia
By PBR Staff Writer
US-based biopharmaceutical firm CymaBay Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for MBX-8025 to treat patients with hyperlipoproteinemia types I or V (Fredrickson classification).
Regulatory Affairs > News
FDA accepts for filing Bayer's sBLA for Betaconnect to treat RRMS
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted the filing Bayer's supplemental biologics license application (sBLA) for Betaconnect (proposed name), another delivery option for Betaseron (interferon beta-1b), a treatment for relapsing-remitting multiple sclerosis (RRMS).
Regulatory Affairs > News
Pfizer's lung cancer drug Xalkori gets FDA breakthrough therapy status
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Pfizer's Xalkori (crizotinib) to treat patients with ROS1-positive non-small cell lung cancer (NSCLC).
Regulatory Affairs > News
Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems
| By SHL Technologies
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.
Regulatory Affairs > White Papers
Design-To-Build – Laboratory Handling Equipment
| By SHL Technologies
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.
Regulatory Affairs > White Papers
Complex Module Manufacturing – IC testing Devices
| By SHL Technologies
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Specialised Project & Technology Transfer – Precision Neurosurgical Equipment
| By SHL Technologies
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.
Regulatory Affairs > White Papers
Supply Chain Management – Surface Mount Technology & Solar Cell Manufacturing
| By SHL Technologies
A leading provider of screen printing equipment located in the UK with an established presence in China was looking for a manufacturing partner that was capable of taking over their supply chain management while maintaining international quality standards. With markets largely located in Asia, the company hoped to find a partner within the region that not only possessed the key manufacturing capabilities required, but one that could also offer western style management to ensure that the technology transfer would go smoothly.
Regulatory Affairs > White Papers
SHL Technologies to Exhibit at MEDTEC Europe 2015
SHL Technologies, a group company of SHL Group, will be exhibiting at MEDTEC Europe 2015 in Messe Stuttgart Germany from April 21 – 23 at Booth#D61 in Hall 5.
Regulatory Affairs > Press Releases
SHL Technologies introduces Case Studies
As contract manufacturing company that provides various manufacturing services to the medtech industry, SHL Technologies has over the years gained a credible track record of successful project collaborations. To help better connect with current and potential customers, SHL Technologies has selected 5 unique case studies to not only showcase the diverse and robust manufacturing capabilities the company offers, but how they are applied and executed to ultimately result in high quality end-products.
Regulatory Affairs > Press Releases
Amgen gets FDA approval for heart failure drug Corlanor
By PBR Staff Writer
Amgen has secured approval from the US Food and Drug Administration (FDA) for Corlanor (ivabradine), an oral medication, to reduce the risk of hospitalization for worsening heart failure.
Regulatory Affairs > News
Abbvie's HCV treatment ombitasvir/paritaprevir/ritonavir gets priority review in Japan
By PBR Staff Writer
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for AbbVie's investigational product ombitasvir/paritaprevir/ritonavir to treat chronic hepatitis C.
Regulatory Affairs > News
AstraZeneca's cancer drug tremelimumab obtains FDA orphan drug status
By PBR Staff Writer
The US Food and Drug Administration has granted orphan drug designation for AstraZeneca's anti-CTLA-4 monoclonal antibody, tremelimumab, to treat patients with malignant mesothelioma, a rare type of cancer.
Regulatory Affairs > News

PBR Supplier Recommendations

ERT - Getting it done. Right.
ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.... Regulatory Affairs > Suppliers
3R PHARMA CONSULTING - Reducing Regulatory Risk
3R PHARMA CONSULTING provides cost-effective, timely solutions to registration filings and challenges in pharmaceutical development strategies across Europe, the US and the rest of world. ... Regulatory Affairs > Suppliers
SHL Technologies - Contract Development and Manufacturing
SHL Technologies is a Contract Development and Manufacturing Organisation (CDMO) that provides OEM and ODM services for various industrial sectors from electronics to healthcare and medical.... Regulatory Affairs > Suppliers
NNIT - The Full Service IT Consultancy Dedicated to Life Sciences
NNIT specialises in using IT to optimise the complex processes inherent in the life sciences industry. We are an international consultancy in the development, implementation, validation and operation of IT for the life sciences industry. ... Regulatory Affairs > Suppliers
7PSolutions - Climate Control Solutions
7PSolutions™ was founded in 2010 to fulfill an unmet need in the life sciences and transportation industries: a single solution for climate control, security and quality management through every stage of the supply chain. ... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

Specialised Project & Technology Transfer- Laboratory Equipment & Automated Systems By SHL Technologies
A US-based company dedicated to developing intelligent inspection solutions and equipment for the biotechnology, pharmaceutical, and medical device industries wanted to partner with an established manufacturer, possessing design and engineering capabilities as well as appropriate in-house quality systems. With lab equipment that finds defects in medical syringes, vials, cartridges, test tubes, and other medical containers, it was vital for the manufacturing partner to have ISO13485 and ISO9001 quality systems in place.... Regulatory Affairs > White Papers Design-To-Build – Laboratory Handling Equipment By SHL Technologies
A leading high-end laboratory handling and diagnostics equipment manufacturing company devoted to helping scientists meet challenges regularly faced in the lab, approached SHL Technologies with a request to develop benchtop laboratory tube array handling equipment. This equipment had to be available in a modular set-up and capable of pick-and-place sorting, weight measurement, and barcode reading.... Regulatory Affairs > White Papers Complex Module Manufacturing – IC testing Devices By SHL Technologies
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers Specialised Project & Technology Transfer – Precision Neurosurgical Equipment By SHL Technologies
An established manufacturer of Integrated Circuit (IC) testing equipment from Germany was following a global sourcing initiative and needed to search for a suitable supplier in Asia that had experience in manufacturing and offered strong production capabilities. Sustaining high quality manufacturing in an environment with established quality systems was vital to the manufacturer and became one of the key determining factors when choosing the right supplier.... Regulatory Affairs > White Papers Supply Chain Management – Surface Mount Technology & Solar Cell Manufacturing By SHL Technologies
A leading provider of screen printing equipment located in the UK with an established presence in China was looking for a manufacturing partner that was capable of taking over their supply chain management while maintaining international quality standards. With markets largely located in Asia, the company hoped to find a partner within the region that not only possessed the key manufacturing capabilities required, but one that could also offer western style management to ensure that the technology transfer would go smoothly.... Regulatory Affairs > White Papers See more
1-15 of 3249 results