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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,...

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

Marken | 10-Sep-2013 | Webinar On-Demand Supplier Webinar
Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reaso...