505(b)(2): It’s A Different Animal
Camargo
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News headlines
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- US FDA Rebukes Alexion APIs, Pfizer Italian Subsidiary in Warning Letters
- India, China Fall Behind in Preparation for New EU API Rules
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Products
Technical / white paper
Best Practices for Achieving and Maintaining Aseptic Conditions During Sterility Testing - SGS
03-Dec-2012 -
Sterility testing is required for companies producing pharmaceutical products and consistent and meticulous testing is essential to obtain results that accurately represent the sterility status of a batch. Download this article for the best practices
Technical / white paper
INFLUENZA TREATMENT CLINICAL TRIALS: CLINICAL CASE STUDIES - SGS
19-Nov-2012 -
Development of influenza vaccines is critical; but, there is also a need for new influenza treatments. This article presents an overview of challenges faced when conducting an influenza treatment study based on two recently managed clinical trials.
Case study
Extractables & Leachables Risk Assessment - SGS
22-Oct-2012 -
An extractables and leachables case study describes how a comprehensive risk assessment was performed across the entire production process of a European manufacturing plant for 40 finished products, resulting in a global testing plan.
Technical / white paper
New Early Phase Concepts: Practical Implementation - SGS
03-Sep-2012 -
There is an urgent need to use innovative techniques in early development. This paper will discuss several case studies in which new clinical trial methods were employed during the early phase clinical development of therapeutic compounds.
Technical / white paper
Vaccine-Based Clinical Trials - SGS
09-Jul-2012 -
Download this paper to read two case studies which illustrate strategies for planning and implementing a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
Technical / white paper
Sample Prep Proposed USP<233> Elemental Impurities - SGS
27-Feb-2012 -
Proper sample preparation is crucial when analyzing for trace metals using inductively coupled plasma (ICP). This paper illustrates how solubility of the test article may not be the primary factor when choosing a sample preparation method.
Technical / white paper
New Challenges in Early Clinical Development - SGS
24-Jan-2012 -
With many new challenges in early clinical development there is pressure to change how early phase clinical trials are conducted where the final goal is to shorten the time to go-no-go decisions and decrease cost. It is increasingly important to...
Technical / white paper
Improving Signal Detection in Drug Safety - SGS
07-Nov-2011 -
Early identification and management of emerging drug safety issues are a major concern of industry stakeholders. Electronic capture systems for AE reporting now allow for faster accumulation of data and the ability to perform complex analysis.
Technical / white paper
White Paper: Vaccine-Based Clinical Trials - SGS
26-Sep-2011 -
Download this paper to read two case studies which illustrate strategies for planning and implanting a vaccine-based infectious disease clinical trial versus a therapeutic-based trial.
On-Demand Supplier Webinar
Diversity for catalysts – assuring speedy and versatile solutions for scale up success - DSM Pharmaceutical Products
03-Feb-2011 -
Wondering how DSM’s unique collection of thousands of catalysts leads to speedy and versatile solutions for scale up success? We will show you how broad chemical and biological diversity increases the chance to successfully identify catalysts
Suppliers
Almac Group
Integrated Solutions from Research to Commercialisation. Almac is a financially secure, privately owned organisation with over 3,300 employees located within the US and UK. Over 600 companies worldwide, including all the market leaders, use our services, testament itself to the quality, innovation and efficiency of our business as proven over the past 30+ years.
Fisher Clinical Services
Fisher Clinical Services is a leading provider of global clinical supply solutions.
DPT
DPT, a DFB Pharmaceuticals, Inc. company, is a contract development and manufacturing organization (CDMO).
Novasep
Novasep combines the expertise of specialists in purification processes and chemical synthesis. We strive to provide our customers with the best solutions for obtaining pure active molecules.
SPS Pharma Services - Contract Research Organization
”Time to market" is the main reason for outsourcing. Sometimes even a basic feasibility study carried out at a critical decision making step can offer a quicker return and also free up invaluable resources for more pressing research.
Genzyme Pharmaceuticals
Genzyme Pharmaceuticals, a business unit of Genzyme Corporation, provides over 25 years of experience to pharmaceutical and biotechnology companies in the area of custom manufacturing complex pharmaceutical materials and specialty chemicals. Our approach to the custom manufacturing market starts at...
