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| home > white papers > Key to Outsourcing Method Development and Validation: A Pragmatic Approach - RSSL |
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 WHITE PAPERS |
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RSSL
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+44 (0)118 918 4024
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http://www.rssl.com
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Key to Outsourcing Method Development and Validation: A Pragmatic Approach
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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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News and Press Releases |
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Huge boom in Korean Pharma reported at CPhI Korea
Amsterdam, 19th September 2019: The recently-closed CPhI Korea – co-organised by Informa Markets and the Korea Pharmaceutical Traders
Association (KPTA) – has seen a surge in growth across domestic and
international pharma companies, as well as a sizable rise in overall
attendees. As reported earlier this year in the provisional findings of
the CPhI Pharma Index[1], Korea has seen a rapid growth in its
international reputation (seeing its ‘overall competitiveness’ rise 14%
in the last two years), which is now translating into a sizable growth
in the market and at the event.
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Trial Timelines
Thomson Reuters
Save resources with accurate trial length projections. How analytics based on curated content can deliver insight for clinical strategies.
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Industry Events |
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Clinical Trials Europe | Partnerships, Outsourcing, Operations & Technology
27 August - 21 November 2019, Barcelona, Spain
On 19-21 November 2019, the clinical trial community's most influential stakeholders will be meeting in Barcelona to discuss the evolving landscape, honing in on what it takes to harness true value from partnerships, outsourcing, operations, technology and early clinical development, for a faster, more efficient route to market.
More info >> |
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