505(b)(2): It’s A Different Animal
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Service Sectors > Supply chain, logistics
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News headlines
- Yusen to Fly AstraZeneca's Drugs to Australia
- Wuxi Manufacturing Services Help Increase Quarterly Earnings
- McKesson Confident FY2014 Will See Revenue Growth
- Lonza Closes Ireland Site as US Manufacturing Issues Cause Increlex Shortage
- Ohio District Court Ruling Against Medpace Could Set Bar for MSAs
- 'Many Moving Parts' Subdue AmerisourceBergen's Q2 Results
- US Congress Needs to Establish Firm T&T Timeline, Standards, Stakeholders Say
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?
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.
On-Demand Supplier Webinar
Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken
25-Mar-2013 -
2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry
Implement clinical development methodologies for quality, relationships, and performance
Strategies to optimize drug development to reduce global trial time and costs
On-Demand Supplier Webinar
Working with the cold harsh reality of temperature controlled supply chains - Marken
06-Mar-2013 -
What are the regulators telling us?
Dealing with a non-harmonized, multi-agency, global challenge.
Monsters Vs, Aliens
How to navigate the maze of import & export regulators.
Thinking beyond the box!
Packaging selection – A different horse for every course
Validation & Qualification – Where are...
On-Demand Supplier Webinar
Optimizing your Strategy and Budget for Clinical Trial Supply Distribution - Marken
20-Feb-2013 -
How to determine if a depot or direct to site shipments are more efficient
Calculation based on a case study
How to avoid delays and assure that your shipments arrives without delays and excursions
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...
Case study
VENDOR MANAGED INVENTORY - Recipharm AB
11-Feb-2013 -
VENDOR MANAGED INVENTORYCONTINUED GROWTH IN DEMAND FOR VMI Vendor Managed Inventory (VMI) can be defined as a means of optimising supply chain performance in which a chosen outsourced manufacturer partner is responsible for maintaining their customer’s inventory levels. The manufacturer has...
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...
On-Demand Supplier Webinar
Cost Effective Data Standards Implementation: How to Integrate CDISC Standards into Your Product - Rho
26-Jun-2012 -
Based on recent guidance from FDA, a data standards plan is now expected at the IND stage of development. Join David Shoemaker, PhD and Jeff Abolafia, MA as they discuss cost effective methods for integrating CDISC data standards into your...
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.
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.
Recipharm AB
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1,700 employees.
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.
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.
World Courier
With a fully integrated GxP-compliant transport, storage and distribution system in place and over 150 wholly-owned ISO 9001-certified offices in more than 50 countries, WORLD COURIER is the world’s largest and most experienced specialty courier company. It is uniquely positioned to meet the most demanding industry requirements for managing time- and temperature-sensitive clinical trial materials used in global studies.For over three decades, World Courier has set the industry standard for delivering customised global transport services to pharmaceutical and clinical trial professionals − providing transport, cold chain and logistical solutions for thousands of international clinical trials.
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.
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.
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.
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).
