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Analysis of Biopharmaceuticals to Conform to ICHQ6B -

24-Jul-2014 - Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%.In 2010 the average...
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Customs Warehouses Benefit Clinical Trial Supply Chain - Marken

11-Jun-2014 - Marken’s new customs-bonded warehouse within the Marken depot in Frankfurt, Germany allows Marken to store pharmaceuticals with an origin outside the European Union (EU) and distribute them to non-EU countries without undergoing the EU importation procedure for pharmaceuticals.
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Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody -

19-Jun-2014 - Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental...
Download now!Clinical study

Learn the risk factors of metabolic syndrome and the role central labs play in aiding its detection - ACM Global Central Laboratory

17-Jun-2014 - Metabolic syndrome, a serious condition impacting adults and children in all genders, races and ethnicities, can lead to fatal outcomes if not detected and treated. The key risk factors of metabolic syndrome were identified approximately 250 years ago. However, there...
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Are there Any Markets left to Emerge? - World Courier

02-Jun-2014 - North America, Western Europe and—to a lesser extent—Australasia once served as prime locations for the majority of research. But these Western markets are approaching saturation, which has led to a lack of naive patients who are available and willing to...
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The Promise and Challenge of Adaptive Design: Oncology Trials - Medpace

05-May-2014 - Incorporating adaptive design methodologies into clinical trials can reduce costs while maintaining trial integrity.  Learn how these design strategies can improve the effectiveness and efficiency of oncology studies
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Shipping with Active Packaging Containers - World Courier

22-Apr-2014 - It is the dead of winter in the northern hemisphere and the height of summer in the southern, with external temperature fluctuations exceeding 50 degrees. Flight delays have added precious days to the transport of your multi-million dollar shipment of...
Download now!Data sheet

A year on, EU GDP’s affect on European Pharma Distribution - World Courier

24-Mar-2014 - World Courier welcomed the EU GDP guidelines, which created a yardstick by which logistics providers could be measured and compared.  A year on from the draft publication it is now fully in force and there has already been an update...
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Ensuring cold chain remains cold and controlled room temp remains controlled! - World Courier

24-Feb-2014 - The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations for pharmaceutical distribution have undergone qualification testing for frozen, refrigerated and controlled room temperature conditions at extreme...
Download now!Application note

RECIPHARM: WHY CONTINUOUS AUDIT READINESS IS CRUICAL - Recipharm AB

20-Jan-2014 - Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that enables the company to be in a state of continuous inspection readiness. Recipharm, one of the busiest and most highly regarded...
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Clinical Document distribution - Secure and Automated - PharmaSOL

08-Jan-2014 - psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation paths, with full receipt tracking. Recipients don't have to learn a new system, and your internal overhead is dramatically reduced.psiXchange...
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Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing - Fujifilm

18-Nov-2013 - Over the last 10-15 years, it has become common practice to manufacture biologics intended for clinical trials (Investigational Medicinal Products, or IMPs) in multi-purpose facilities.This flexibility has been a key enabler in ensuring a flow of novel products, frequently targeting...
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Controlled Release and Bioavailability Enhancement -

28-Oct-2013 - Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery •    Bioavailability Enhancement •    Taste Masking (liquid and solid presentations)When applied appropriately, these technologies can deliver therapeutic and convenience benefits to...
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505(b)(2): 10 Years and Running with 300+ Approvals - Camargo

21-Oct-2013 - In 2003, the FDA unleashed the 505(b)(2) pathway. With a record 47 approvals in 2012, the pathway is helping product developers secure up to 7 years of market exclusivity.Visit us at AAPS booth 4304 and read our white paper to learn more.
Watch now!On-Demand Supplier Webinar

New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
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HEPATITS C VIRUS – RACE FOR TREATMENT - SGS

23-Sep-2013 - To understand why there is so much buzz in the pharmaceutical world for a better HCV treat­ment, as with most things, you have to start with history. This article will highlight the history, why there is a growing need for...
Watch now!On-Demand Supplier Webinar

Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis - SGS Life Science Services

30-Aug-2013 - 2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Correctly interpreting the analytical requirements in these regulations is critical to demonstrate Biosimilarity. This webinar will review the evolution of...
Watch now!On-Demand Supplier Webinar

Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
Download now!Case study

Creating and capturing value for outsourcing pharmaceutical manufacturing - Recipharm AB

15-Jul-2013 - An efficient technology transfer process can create value as well as capture it for pharmaceutical companies and CMOs alike.Discover the mutual benefits of working with Recipharm. Because technology transfer has both legal and economic implications, working with an experienced outsourcing manufacturer...
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Understanding the 505(b)(2) Approval Pathway - Camargo

11-Jun-2013 - When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...

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