505(b)(2): It’s A Different Animal
Camargo
Service Sectors > Validation services
All service sectors
News headlines
- CROs, Sponsors Look to Service Providers to Comply with US Sunshine Act
- ACRO Calls for Clarity on FDA Draft Guidance on eSource Trial Data
- Outsourcing-pharma.com 2012 Quiz
- Payment based on CRO results is the wave of the future: iGate
- BioFocus gives itself room to update compound library
- iGATE says new data management tech will change R&D
- SGS opens assay lab in France
Products
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
ePathology Improves Data Accuracy & Study Productivity! – Amicus Study Confirms - Aperio
20-Mar-2013 -
With current glass slide methods, sharing and scoring slides within a study from one pathologist to another at a different organization or site, meant that slides had to be packed, shipped and tracked. Often the reading pathologist was required to...
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
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...
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.
On-Demand Supplier Webinar
Targeted Product Development: Personalized Medicine versus Orphan Product Development - Rho
31-Jul-2012 -
The development of therapeutics for personalized medicine leverages many of the advantages of the legislation conferred upon orphan products. New products must be positioned intelligently to take advantage of this legislation. Join David Shoemaker, Ph.D. as he discusses the benefits...
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.
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.
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.
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.
Alkermes Contract Pharma Services
Alkermes Contract Pharma Services provides product development scale-up and manufacturing services to the pharmaceutical market and is part of Alkermes plc. With over 40 years in the service business, we have assisted our blue chip list of partners in the successful launch of multiple products in more than 100 countries, including North America, Europe and Asia.
Recipharm AB
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1,700 employees.
Solvias AG - Chemical and analytical development
With our services, products and technologies Solvias provides integrated solutions to enhance the value-chain for customers in the pharmaceutical and biopharmaceutical industry worldwide.
Famar
Established in 1949, Famar is one of Europe’s leading providers of Contract Development and Commercial Manufacturing services to the pharmaceutical and personal care industries. We are presently within the Top 5 & Top 3 worldwide and in Europe respectively -based on Volumes (700mio packs) and Turnover (€ 380M).
