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Service Sectors > Regulatory affairs
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News headlines
- Parexel Backlog May Indicate Future Revenue Boom
- Aussie Contract Pharma Packager Hit with US FDA Warning Letter
- EU Data Protection Amendments Could Make Medical Research Impossible, Professors Say
- EU Clinical Data Transparency One Step Closer as Draft Regs Approved
- FDA Warns Hospira Again, This Time in India
- US FDA Recommends CMO Quality Agreements in Long-Awaited Draft Guidance
- Ethica Picks Alion for Human Research Protection Accreditation
Products
Technical / white paper
Understanding the 505(b)(2) Approval Pathway - Camargo
11-Jun-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Data sheet
505(b)(2): It’s A Different Animal - Camargo
13-May-2013 -
505(b)(2) is more than just a regulatory pathway, it is a distinctly different animal — a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. Find out if 505(b)(2)...
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?
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
Technical / white paper
What Makes 505(b)(2) Different? - Camargo
19-Mar-2013 -
When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
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
Application note
RECIPHARM: WHY CONTINUOUS AUDIT READINESS IS CRUICAL - Recipharm AB
15-Apr-2013 -
Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that enables the company to be in a state of continuous inspection readiness. Recipharm, one of the busiest and most highly regarded...
Case study
Increasing Accuracy, Not Costs - Mettler Toledo
11-Apr-2013 -
Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects from retailer shelves. One major pharmaceutical manufacturer came to Mettler-Toledo CI-Vision hoping to reduce the rate of defective...
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...
Technical / white paper
Identifying the Product - Camargo
06-Feb-2013 -
When it comes to developing a compound, the 505(b)(2) pathway can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process from concept through commercialization to identify products with documented market differentiation:
Selection...
Suppliers
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.
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.
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
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.
INC Research
INC Research is a therapeutically focused global clinical research organization (CRO) with unrivaled expertise and a reputation for conducting global clinical development programs of the highest integrity.
Recipharm AB
Recipharm AB is a leading contract development and manufacturing organisation (CDMO) based in Sweden employing some 1,700 employees.
PharmaNet
PharmaNet, a recognized leader of global drug development services to the pharmaceutical, biotechnology, generic drug, and medical device industries, provides comprehensive capabilities in Phase I-IV clinical development, bioanalytical and bioequivalence services, regulatory consulting, staffing, and therapeutic solutions.
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BioPharm America™ 2013—6th Annual International Partnering Conference
Boston, MA, USA / Conference
