505(b)(2): It’s A Different Animal
Camargo
Service Sectors > Analytical testing, QC
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News headlines
- Dedicated Analytical Expansion Could Target New Clients, says Kemwell
- Hospira says Troubled Plant on 'Rocky' Road to Recovery
- Thermo Fisher Acquires Life Tech for $13.6B
- Client Demand Pushes Early Phase Australian CRO to Expand to Large Molecules
- Preclinical CRO Pushes into India to Reduce Human Bioequivalence Studies
- US FDA Rebukes Alexion APIs, Pfizer Italian Subsidiary in Warning Letters
- Janssen Releases Additional Doxil Lot via Alternative Manufacturing Approach
Products
Live Supplier Webinar
Supply Chain Issues and Trends in Asia - Marken
02-May-2013 -
Import/export of biological samples from China
China: Large Pharma Reverse Logistics
A Common Issue: Destruction of Drug in Taiwan
J-GMP: How is GMP different in Japan?
Korea: Biosimilars Hotbed
India: Will Regulations Change to Allow Quicker Study Approval in 2013?
Technical / white paper
White Paper: Is My Method Still Valid? - SGS
26-Mar-2013 -
The goal of method validation is to provide proof that data from each individual sample is indicative of the actual batch content with little deviation. This paper outlines the importance of validation as well as the official requirements, including characteristics...
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
Biosafety Testing: In Vitro Virus Detection - SGS
09-Oct-2012 -
Regulatory authorities (US FDA and the EMEA) impose stringent limits on the amount of microbial contaminates and impurities present during the manufacturing of biological medicines and vaccines.One area of concern is that the cell substrates used in the production of...
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.
Data sheet
Enhanced Rheumatoid Arthritis CIA and CAIA Studies - Molecular Imaging Inc.
23-Jul-2012 -
Detect disease modification with biomarker imaging using PET, FMT & CT to assess treatment response. Enhance decision making with
complementary end points
minimized histopathology
Improve your next RA Study–contact us at marketing@molecularimaging.com
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
Implementing LEAN Techniques in Quality Control - Baxter
17-Apr-2012 -
Applying LEAN techniques can result in improved productivity, workflow efficiency and cost savings. The Quality Control Laboratory at Baxter’s contract manufacturing facility in Halle/Westfalen, Germany, has been applying LEAN techniques since 2007 with the goal of reducing release lead times....
Suppliers
A global force in central lab testing
ACM Global Central Lab is a global force in central laboratory testing for clinical trials. We specialise in delivering the highest quality laboratory science in support of clinical research services. Our flexible approach, attention to detail and customer service sets us apart from the competition.
Vetter Pharma International GmbH
Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials.
Recipharm AB
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1,700 employees.
Fresenius Kabi Product Partnering
Fresenius Kabi Product Partnering leads the way in contract development and manufacture of sterile pharmaceuticals and medical devices. As Fresenius Kabi’s business-to-business platform we are dedicated to contract manufacturing and offer our partners easy access to our worldwide development and manufacturing capabilities.
DPT Laboratories
With a specialized focus on semi-solids and liquids, DPT offers pharmaceutical companies the broadest range of capabilities in the industry. From R&D formulation to commercial-scale manufacturing, small batches to large, liquids to emulsions, sterile or non-sterile, we offer clients of all sizes the most effective resources for meeting challenges.
LabConnect, LLC
LabConnect provides global central laboratory services including routine and esoteric laboratory testing, kit building, sample management and tracking, biostorage and scientific support services for our biopharmaceutical and CRO clients.LabConnect’s services include:Specialized Testing. With more than 4,000 validated tests across our network, LabConnect can handle everything from general safety testing to the most complex molecular diagnostics and biomarker analyses. LabConnect’s extensive test menu includes a broad range of validated assays and diagnostic platforms as well as method development and validation services.Specimen Tracking. LabConnect’s real-time specimen tracking service, SampleGISTICS™, follows the clients’ specimen samples from collection through logistics to receipt at any lab or storage location in the world. LabConnect provides enhanced visibility of each individual sample and our advanced virtual accessioning process enables immediate query resolution, thereby improving efficiencies and saving time and money for our clients.Scientific Operations Support. LabConnect provides dedicated contract scientific professionals based upon the specific functional expertise our clients require. Our SciOps services give our clients management control without the time and cost strains of managing internal headcount, payroll and human resource issues.Biostorage Solutions. LabConnect offers a comprehensive suite of biostorage solutions for multiple sample types.Clinical Kits. LabConnect custom designs, builds and distributes visit-specific collection kits with pre-labeled tubes to minimize errors. Our kits are consistently rated as some of the best in the industry by investigator sites.
ROVI Contract Manufacturing
Contract manufacturing and pharmaceutical co-development through our 2 manufacturing plants located in Madrid, Spain. Both plants belong to Laboratorios Farmacéuticos ROVI: pharmaceutical company founded in 1946 and listed in the Madrid Stock Exchange Market since 2007. Revenues from 2011 were 184.7€ M and it takes count with over 840 employees.
Kemwell Biopharma Inc
Kemwell Biopharma is contract provider of CMC services to the pharmaceutical industry. With manufacturing locations in Bangalore India, and Uppsala Sweden, Kemwell offers services ranging from Clinical (CTM) Manufacturing, Commercial Manufacturing, Biopharmaceutical Manufacturing, Formulation Development, Analytical Development, Stability Testing & Packaging/Storage/Distribution.
SGS Life Science Services
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.
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.
