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Ensuring cold chain remains cold and controlled room temp remains controlled!

World Courier | 20-Feb-2014 | PDF Technical / white paper
The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations fo...
Global Disposable Concept at Boehringer Ingelheim

Global Disposable Concept at Boehringer Ingelheim

BOEHRINGER INGELHEIM GmbH | 07-Feb-2014 | PDF Technical / white paper
Boehringer Ingelheim is one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals. We are a g...

Footprint-Free™ Cell Line Engineering Services at Transposagen

10-Feb-2014 | PDF Technical / white paper
Altering the genome of cells is a powerful and increasingly necessary tool for drug discovery and research. Transposagen utilizes its exp...

Preparation of Pharmaceutical Samples for Metals Analysis

25-Nov-2013 | PDF Technical / white paper
With proposed changes to elemental impurities requirements for pharmaceutical products currently being reviewed, spectroscopic techniques...
Marken

Customs Declared Value - What this means for the global clinical supply chain

Marken | 03-Dec-2013 | Webinar On-Demand Supplier Webinar
What valuation is and how is it used by Customs authorities and other government agencies How to use the six approved valuation metho...

Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing

Fujifilm | 12-Nov-2013 | PDF Technical / white paper
Over the last 10-15 years, it has become common practice to manufacture biologics intended for clinical trials (Investigational Medicinal...

METHOD VALIDATION – USP PROPOSED

SGS | 01-Nov-2013 | PDF Technical / white paper
The USP is continuing to modify a proposal for using inductively coupled plasma (ICP) and ICP-mass spectroscopy (ICP-MS) to detect contam...

Controlled Release and Bioavailability Enhancement

25-Oct-2013 | PDF Case study
Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Custom...
Optimizing your Strategy and Budget for Clinical Trial Supply Distribution

Optimizing your Strategy and Budget for Clinical Trial Supply Distribution

Marken | 13-Nov-2013 | Webinar On-Demand Supplier Webinar
This presentation will discuss: How to determine if a depot or direct to site shipments are more efficient Calculation based on a case...

505(b)(2): 10 Years and Running with 300+ Approvals

Camargo | 16-Oct-2013 | PDF Data sheet
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...

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

Baxter | 19-Nov-2013 | Webinar On-Demand Supplier Webinar
Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been deve...

Making a safe choice for the manufacture of hormones

Recipharm AB | 11-Oct-2013 | PDF Case study
As consumer demand for hormones increases worldwide, and formulations for manufacturing advance from microgram to milligram levels, what...
Marken

Trade Compliance and Pharma: What you need to know about the trade aspects of your global studies

Marken | 15-Oct-2013 | Webinar On-Demand Supplier Webinar
This webinar will explore the basics of trade compliance for pharmaceutical products: Overview of global trade compliance Trade compli...
sgs

Nucleic Acid Amplification Technique for Biosafety

SGS Life Science Services | 02-Sep-2013 | PDF Technical / white paper
Use of cutting-edge NATs reduces the amount of time needed for development and safety testing of novel biotech products. This white paper...

Clinical Document distribution - Secure and Automated

PharmaSOL | 17-Sep-2013 | PDF Case study
psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user s...
SGS

HEPATITS C VIRUS – RACE FOR TREATMENT

SGS | 20-Sep-2013 | PDF Technical / white paper
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 w...
Vetter Pharma

Meeting the challenges of complex drug substances

Vetter Pharma International GmbH | 29-Aug-2013 | PDF Technical / white paper
Realizing the full potential of an injectable drug compound is no small task. In the months and years that lead from the discovery phase...

Patient Reminders: Improve Retention & Compliance

Cenduit | 02-Sep-2013 | PDF Technical / white paper
The average cost of a patient lost to follow-up is $5,000.  Read on to learn how to incorporate patient reminders into your protocol...

Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis

SGS Life Science Services | 09-Oct-2013 | Webinar On-Demand Supplier Webinar
2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Corr...

(b)(2) or not (b)(2)? That is the question.

Camargo | 14-Aug-2013 | PDF Technical / white paper
505(b)(2) is more than a regulatory pathway - for many, it’s a unique strategy that can often result in product approval with lower risk,...

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