505(b)(2): It’s A Different Animal
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Service Sectors > Phase III-IV
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News headlines
- US House Bill Aims to Expand Release of Clinical Trials Data
- Quintiles’ Lead Medical Expert: Real World Patient Data Hold Enormous Potential
- PRA Prepares to Go Public with Confidential SEC Filing
- PPD Subsidiary Expands Biopharma Services with New China Lab
- Quintiles Signs Exclusive Development Deal with Merck Days After $1B IPO
- Wuxi Manufacturing Services Help Increase Quarterly Earnings
- Lack of Milestones Affect Q1 but Evotec Optimistic for Future
Products
Live Supplier Webinar
Antibody Drug Conjugate Development and Manufacture - Piramal
03-May-2013 -
With the recent approvals of brentuximab vedotin (Adcetris) and ado-trastuzumab emtansine (Kadcyla,T-DM1), antibody–drug conjugates (ADCs)are a rapidly growing area in oncology with great potential. Development and manufacture of ADCs can be a challenge with the requirement to handle both biologics...
On-Demand 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?
Case study
A risk assessment framework for donor and recipient companies to jointly analyze and document the technical and business risks associated with the technical transfer of pharmaceutical product - Alkermes
22-Apr-2013 -
Every technical (tech) transfer is different, with companies taking different paths toward reaching their goal. Each one presents a unique set of challenges. These challenges are most often technical, but at times they may also be business related. However all...
Technical / white paper
Clinical Trial Logistics in Africa: Ensuring Quality, Compliance and Control within the Pharmaceutical Supply Chain - World Courier
01-Jan-2013 -
WORLD COURIER is the market leader in the handling, transport, storage and distribution of temperature-sensitive pharmaceutical products and biological specimens in Africa and worldwide. It offers a fully-integrated GxP-compliant pharmaceutical supply chain system, strong knowledge of the local regulatory environment,...
Technical / white paper
New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers - World Courier
11-Feb-2013 -
World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel and infrastructure closer to key customers in Switzerland and Austria with the recent opening of offices in Basel and Innsbruck.At the same...
Video
The Best of Both Worlds: Swiss Quality, Made in China - Lonza
05-Feb-2013 -
Lonza brings you the best of both worlds with Swiss quality manufacturing of APIs available at our FDA approved facility in Nansha, China. From backward integration to tailored production concepts for efficient manufacturing, Lonza offers sustainable solutions for regionally important...
Case study
Blinding Techniques for Inhaler Devices - Development of a Novel Blinding Methodology for a Market Leading DPI - Almac Group
21-Jan-2013 -
Blinding inhalers for use in clinical studies is a challenging and specialised area of clinical trial supplies. In this case study, Almac provide a real life overview of their unique inhaler blinding services which have been successfully developed and validated,...
Case study
Alkermes successful approach to commercial-scale, final dosage manufacture of drug product containing highly potent API for a global pharmaceutical company. - Alkermes
18-Dec-2012 -
As part of Alkermes plc, Alkermes Contract Pharma Services, provides solid oral dosage product development, scale–up and manufacturing services as well as sterile fill finish capabilities to the global pharmaceutical market. This case study demonstrates how a commercial manufacturing partnership...
On-Demand Supplier Webinar
Using FDA’s Draft Guidance on Risk-Based Monitoring to Improve Clinical Data Quality - Rho
15-Oct-2012 -
The Industry’s changing approach to clinical data monitoring requires the tools and team structure to effectively plan and execute risk-based monitoring. Join Lynn King and Rob Woolson as they discuss multi-disciplinary approaches to implementing alternative monitoring plans and specialized tools...
Data sheet
Connecting Perfectly At Every Stage - Parexel
30-Jul-2012 -
We believe in one bond that's more important than all others. Download our brochure to see how PAREXEL can help to optimize your product value.
Suppliers
Piramal Healthcare Ltd
Piramal Pharma Solutions is the Contract Development and Manufacturing (CDMO) arm of Piramal Healthcare and is one of the only CDMOs providing support throughout the entire pharmaceutical drug product life-cycle. We also provide specialty services of Antibody Drug Conjugation & Clinical Trial Supplies for Pharmaceutical Companies across geographies.
Baxter BioPharma Solutions
Sterile Contract ManufacturingWith over 80 years of parenteral experience, BioPharma Solutions (a business unit of Baxter) offers a variety of contract manufacturing form/fill/finish services and solutions for injectables , designed to meet complex and traditional sterile manufacturing challenges. In addition, we are the only CMO to offer a manufacturer-prepared, commercial-scale aseptic filling process for premixed drugs in flexible IV bags.
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.
Marken
Marken is the leading global clinical supply chain solutions provider dedicated to the pharmaceutical and life sciences industries, supporting over 49,000 investigators in more than 150 countries. Marken integrates Depot and Logistics services into solutions that extend the reach of clinical trials to even the most remote treatment naïve geographies, leveraging decades of experience in the logistics, transport and distribution of temperature sensitive life saving pharmaceuticals, clinical trial supplies and specimen collection. Our team members, technologies and network of facilities bridge the distance between patients and the essential resources of life science companies.
Regulatory, Customs and Brokerage for Import/Export assistance
Global movement of API from the point of manufacturing to CMOs and primary packagers
Collection, packaging, storage and delivery of biological test specimens including controlled temperature management
By integrating Depot and Logistics services, Marken offers our customers solutions that can extend the reach of clinical trials to even the most remote areas.Marken Makes It Happen
Temperature-sensitive assets arrive within specification, at temperatures ranging from deep frozen to controlled ambient.
Marken’s unparalleled experience and expertise in customs and regulatory matters results in a 99.8% on-time shipment rate.
Marken’s worldwide depot network provides access to over 49,000 investigator sites in more than 150 countries around the world.
State-of-the art information systems give customers immediate access to the status of shipments as well as inventory levels of critical assets.
CRF Health
CRF Health delivers electronic Clinical Outcome Assessments (eCOA) solutions for global clinical trials. The most innovative Pharmaceutical and Biotechnology companies partner with CRF Health to develop electronic Clinical Outcome Assessment strategies, transition from legacy paper instruments, and manage Clinical Outcome data to gain immediate visibility to patient assessments.
Corden Pharma ~ Experts Taking Care
CordenPharma is a full-service CMO partner in the cGMP Contract Development and Manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients (APIs), and associated Global Supply Chain and Packaging Services.
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.
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.
Founded by Ben Chien in 1995, QPS is a GLP/GCP-compliant contract research organization (CRO) that offers the highest grade of discovery, preclinical, and clinical drug development services. From a humble bioanalysis shop, it has grown into a full service CRO of 900+ employees spread across the US, Europe, India and Asia. Today, it offers a wide array of pharmaceutical contract R&D services and its areas of expertise encompass Neuropharmacology, DMPK, Toxicology, Translational Medicine, and Early Stage & Phase II - IV Clinical Research.In recent years, QPS expanded its later stage capabilities and extended its Asia Pacific and European presence by acquiring Qualitix (Taiwan) and JSW Clinical Investigations (Austria). This growth enabled QPS to facilitate global late stage clinical trials of new drug candidates in diverse therapeutic areas. By acquiring toxicology and neuropharmacology units at DCB (Taiwan) and JSW Life Sciences, respectively, QPS increased its preclinical services as well. The company also expanded its Phase I clinic in the Netherlands, in order to meet growing market demands. By constantly upgrading its capacities and skills, QPS is always more than ready to fulfill its promise to deliver superior quality, skilled performance and trusted service to its valued customers. For more information, visit www.qps.com
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.
