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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...
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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)...
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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?
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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
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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...
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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
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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...
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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...
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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...
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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...
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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,...
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Identifying a Differentiated Product – 505(b)(2) - Camargo

08-Oct-2012 - With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo offers a clear process to identify products that have documented market differentiation.
Download now!Technical / white paper

Identifying the Product - Camargo

26-Sep-2012 - With a generic cliff approaching, the 505(b)(2) development process can make changes to reference products for greater profit potential and lower risk. Camargo Pharmaceutical Services offers a clear process to identify products that have documented market differentiation: Selection criteria Identify, assess and...
Download now!Data sheet

505(b)(2): Fast and Cost-Effective Drug Approval - Camargo

10-Sep-2012 - Looking to identify a new product for development or improve an existing compound? For lower risk, reduced cost and faster speed to market, Camargo Pharmaceutical Services is your go-to expert in the 505(b)(2) pathway. Find out if 505(b)(2) is for...
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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...
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505(b)(2): Fast and Cost-Effective Drug Approval - Camargo

20-Jun-2012 - Looking to embark on a 505(b)(2) product approval?More products than ever are approved via the 505(b)(2) pathway — a fast and cost-effective route for drug approval. With global reach across 26 countries, Camargo Pharmaceutical Services executes 505(b)(2) drug development programs...
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505(b)(2): Fast and Cost-Effective Drug Approval - Camargo

28-May-2012 - As a fast and cost-effective route for drug approval, more products than ever are approved via the 505(b)(2) pathway. Camargo Pharmaceutical Services is your go-to expert for 505(b)(2) approvals that provide product differentiation and a period of market exclusivity.
Download now!Data sheet

Effective Controlled Substances Supply Chain Management - DPT Labs

23-May-2012 - At a time when supply chain management has become increasingly complex, managing the unique challenges of the controlled substance supply chain can seem daunting for companies lacking in‐house capabilities and resources. Effective management of the controlled substance supply chain and...
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Oncology Clinical Trials: Keys to Success in the Era of Personalized Medicine - William Reed Business Media

22-May-2012 - This webinar will give you a better understanding of how the end of one-size-fits all medicine, and current oncology drug developments in diagnosis and biomarkers positively impact clinical trials. It will also address key oncology drug development barriers and best...
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The Road Less Travelled – Navigation through the do’s and don’ts of running Oncology studies in Asia - William Reed Business Media

22-May-2012 - Clinical trials in the Asia Pacific are increasing exponentially.  Numerous sponsors and CROs have accessed this region in recent years to take advantage of high performing, cost effective sites.  To many sponsors though, Asia Pacific appears an impenetrable black box....