505(b)(2): It’s A Different Animal
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On-Demand Supplier Webinar
What Non-statisticians Need to Know about Statistics in Clinical Trials - Rho
04-Apr-2013 -
Through real-world examples, webinar participants learn strategies for choosing appropriate outcome measures, methods for analysis and randomization, and sample sizes as well as tips for collecting the right data to answer your scientific questions.
Insight guide
Analytical Method Development and Validation — A CDMO Perspective - DPT Labs
28-Nov-2012 -
Pharmaceutical drug product development can be an expensive and time consuming process. Many challenges are faced by pharmaceutical development companies including developing a scaleable, marketable formulation, ensuring safety and efficacy of the drug product and receiving approval of the drug...
Case study
Smaller pharma companies financially benefitting from CDMO partnerships - Recipharm AB
26-Nov-2012 -
In today’s global economy, available financing is increasingly scarce for pharmaceutical companies looking to bring new products to market. Find out how risk-sharing practices initiated by Recipharm have made it possible for customers to closely collaborate and share rewards as...
Data sheet
Vetter – Answers that work - Vetter Pharma International GmbH
03-Oct-2012 -
There are many sides to your product’s success. Build them together at Vetter.Whether your injectable is still at the starting line or in full-scale production, there are possibilities all around you. Thoughtful questions that can open new doors. Precisely planned processes that...
Technical / white paper
Pharmaceutical Outsourcing - key success factors - Alkermes
13-Jun-2012 -
It is now considered a sound strategic move by pharmaceutical companies, from big pharma to smaller players, to increasingly rely on outsourcing service providers to fulfil specific tasks, solve problems, and improve efficiency and productivity.While engaging in an outsourcing solution...
Data sheet
Ensuring Quality & Regulatory Compliance w/ Service Providers - DPT Labs
25-Jan-2012 -
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure...
Technical / white paper
Crystallization – Understanding and developing the process - Solvias AG
28-Nov-2011 -
In order to achieve controlled production of a desired polymorphic form it is essential to primarily understand the product and be intimately familiar with the process. Furthermore, scaling up the crystallization process requires an expert team of experienced scientists working...
Case study
Application of a partner-driven approach in winning and maintaining outsourced pharmaceutical business - Alkermes
17-Nov-2011 -
Alkermes' Contract Pharma Services provides solid dosage form product development, formulation solutions and manufacturing services for the pharmaceutical market. With a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide, previously as...
Technical / white paper
Using the Four Pillars to Support Data-Driven Feasibility Success - INC Research
03-Nov-2011 -
Download our latest Foresight articleThe challenges of clinical trial recruitment are well-known to drug developers. Yet while difficulties on the macro level are well-recognized, it is the micro-level details that ultimately determine the success or failure of enrollment efforts in...
On-Demand Supplier Webinar
Continuous Process Improvement for Solid Oral Dose Development - Colorcon
22-Aug-2011 -
Need to improve team collaboration and save time bringing products to market? Then don’t miss this insightful webinar to learn how to expedite excipient selection, transform product design, and achieve product differentiation to gain competitive advantage.
Video
The Future of Healthcare Management - PBI
20-Jun-2011 -
Pacific Biomarkers is a premier biomarker laboratory services provider. We partner with many drug manufacturers to help bring products to market quickly and cost effectively. Dr. Tim Carlson briefly explains our work measuring biomarkers to determine the efficacy and safety...
Event programme
How Will You Innovate? - Biologics-Drug Delivery Sys Dev & Lifecycle Mgmt
17-May-2011 -
Have you been asked to innovate and don’t really know where to start? Learn key concepts and get hands-on experience developing innovative approaches to improve supply chain performance and increase market share at the DCAT/ISM Sourcing Summit on July 13...
Data sheet
Key steps to consider when working with a cdmo to identify optimal packaging options - DPT
28-Mar-2011 -
There are many factors to take into consideration when selecting or designing a packaging component. Steps involved during the initial stage of the process are extremely important in ensuring that the most optimal packaging is identified. Working with a contract...
Video
GxP, World Courier and Clinical Trial Transport - World Courier
21-Mar-2011 -
Dr. Rüdiger Lomb, World Courier’s Global Director, Quality & Technical Compliance, discusses regulatory compliance within World Courier and key capabilities that transport providers must possess to ensure a secure pharmaceutical supply chain.
Technical / white paper
Custom Manufacturing Driven by Core Competencies at Genzyme Pharmaceuticals - Genzyme Pharmaceuticals
21-Sep-2010 -
With global competition in custom manufacturing dramatically shifting, companies are changing business strategies to extend geographic presence, create low-cost production capacities, develop investment-intensive chemistry capabilities, or further leverage existing economies-of-scale. Genzyme Pharmaceuticals’ custom manufacturing business is based on long-standing competencies...
Technical / white paper
Generate Sales Leads: Free White Paper - William Reed Business Media
02-Aug-2010 -
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and establish your company’s reputation as a thought leader. Want to know how to create an effective white paper? Download William...
Survey
Are you Asking the Right Questions? - William Reed Business Media
02-Aug-2010 -
Want to evaluate your company’s brand image or the opinion of the Outsourcing-Pharma readers on a certain topic? Want to perform a market research analysis without the hassle? Download William Reed Business Media’s survey brochure to find out how you...
Technical / white paper
Generate sales leads with a good white paper - William Reed Business Media
24-Mar-2010 -
White papers (or technical papers) are one of the most effective ways to generate leads for your sales team and improve your company’s reputation as an expert. Want to know how to create effective white papers? Download this guide now....
Technical / white paper
The urgent need for qualified transport providers - World Courier
25-Jan-2010 -
In light of sobering statistics from the MHRA, WHO and others about the quality of temperature-controlled drugs and medicinal products arriving at global research sites, regulatory agencies and pharmaceutical companies alike are demanding that every party involved in the pharmaceutical...
Technical / white paper
Validation of Pioglitazone in Human Serum by Two Sample Introduction Methods: LDTD-APCI/MS/MS and LC-ESI/MS/MS - BASi
12-Aug-2009 -
BASi’s expanded European facility provides contract research services - preclinical research, toxicology, bioanalysis, method development and pharmaceutical analysis - as well as specialized instrumentation. Download an example method validated by BASi.
