505(b)(2): It’s A Different Animal
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Service Sectors > Contract sales & marketing
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News headlines
- CROs, Sponsors Look to Service Providers to Comply with US Sunshine Act
- TFS Sees Increase in Modularization, Shorter Construction Timelines
- DKSH Bags Pfizer Deal in Cambodia
- InVentiv Pushes into Highly Sought-After Japanese Market with Collaboration
- ICH Draft Guidance Aims to Help Stamp Out Drug Impurities
- Knipper Reaches Summit of Sample Management Business with InVentiv Purchase
- GSK to Expand Supplier "Risk Mapping" in 2013
Products
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.
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...
Case study
Smaller pharma companies financially benefitting from CDMO partnerships - Recipharm AB
26-Nov-2012 -
In today’s global economy, available financing is increasingly scarce for pharmaceutical companies looking to bring new products to market. Find out how risk-sharing practices initiated by Recipharm have made it possible for customers to closely collaborate and share rewards as...
Data sheet
Vetter – Answers that work - Vetter Pharma International GmbH
03-Oct-2012 -
There are many sides to your product’s success. Build them together at Vetter.Whether your injectable is still at the starting line or in full-scale production, there are possibilities all around you. Thoughtful questions that can open new doors. Precisely planned processes that...
Technical / white paper
Pharmaceutical Outsourcing - key success factors - Alkermes
13-Jun-2012 -
It is now considered a sound strategic move by pharmaceutical companies, from big pharma to smaller players, to increasingly rely on outsourcing service providers to fulfil specific tasks, solve problems, and improve efficiency and productivity.While engaging in an outsourcing solution...
Data sheet
Ensuring Quality & Regulatory Compliance w/ Service Providers - DPT Labs
25-Jan-2012 -
In recent years, the pharmaceutical industry has given greater priority and attention to quality assurance and regulatory compliance than ever before. With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure...
Technical / white paper
Crystallization – Understanding and developing the process - Solvias AG
28-Nov-2011 -
In order to achieve controlled production of a desired polymorphic form it is essential to primarily understand the product and be intimately familiar with the process. Furthermore, scaling up the crystallization process requires an expert team of experienced scientists working...
Case study
Application of a partner-driven approach in winning and maintaining outsourced pharmaceutical business - Alkermes
17-Nov-2011 -
Alkermes' Contract Pharma Services provides solid dosage form product development, formulation solutions and manufacturing services for the pharmaceutical market. With a long and successful history in the development and manufacture of pharmaceutical dosage forms for pharmaceutical markets worldwide, previously as...
Technical / white paper
Using the Four Pillars to Support Data-Driven Feasibility Success - INC Research
03-Nov-2011 -
Download our latest Foresight articleThe challenges of clinical trial recruitment are well-known to drug developers. Yet while difficulties on the macro level are well-recognized, it is the micro-level details that ultimately determine the success or failure of enrollment efforts in...
On-Demand Supplier Webinar
Continuous Process Improvement for Solid Oral Dose Development - Colorcon
22-Aug-2011 -
Need to improve team collaboration and save time bringing products to market? Then don’t miss this insightful webinar to learn how to expedite excipient selection, transform product design, and achieve product differentiation to gain competitive advantage.
Suppliers
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.
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.
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.
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.
Vetter Pharma International GmbH
Vetter is an independent international specialist in the production of aseptically pre-filled injection systems, cartridges and vials. For more than 25 years Vetter has been renowned for its quality, innovation and strategic partnerships.
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.
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.
DPT
DPT, a DFB Pharmaceuticals, Inc. company, is a contract development and manufacturing organization (CDMO).
Genzyme Pharmaceuticals
Genzyme Pharmaceuticals, a business unit of Genzyme Corporation, provides over 25 years of experience to pharmaceutical and biotechnology companies in the area of custom manufacturing complex pharmaceutical materials and specialty chemicals. Our approach to the custom manufacturing market starts at...
