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Pharma Flourishing

“Welcome to CPhI Worldwide 2018! The event returns in what has been a particularly successful year for pharmaceuticals. As an industry, we have seen a truly stellar year for new drugs – with an outstanding 46 FDA approvals in 2017 and many more to come. With the approval of Luxturna heralding a new age of fast-tracked gene therapies, growth in artificial intelligence, and advances in 3D printing, pharma is expecting a time of even greater collaboration and innovation. This year, with more on-site content than ever before, we look forward to welcoming our guests and providing a platform for building relationships that drive business growth,” says Orhan Caglayan, Brand Director Europe, at UBM (part of Informa).

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News and Press Releases

Recro Gainesville Adds New Facility, Broadens Capabilities With High-Potent Processing on Deck

Gainesville, Ga., Nov. 5, 2018 (Business Wire) – Recro Gainesville has added a 24,000-square-foot facility, which includes high-potent material processing space, near its existing 97,000-square-foot contract pharmaceutical development and manufacturing plant. The company is a wholly owned subsidiary of Recro Pharma, Inc., and a leading provider of solid oral dose development and manufacturing services for the pharmaceutical industry.
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White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events

INTERPHEX 2019

2-4 April 2019, Javits Center, New York

At INTERPHEX, find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Product. INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event and sponsored by Parenteral Drug Association (PDA). Dedicated to Innovation, Technologies and Knowledge, the show focuses on the entire product development life cycle.
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