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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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Turkish Cargo maintains its dual-terminal operations seamlessly
Completing the gradual transition process to Istanbul Airport, one of the largest airports of the world, the global air cargo brand Turkish Cargo maintains its dual-terminal operations with full capacity on 7/24 basis without any sales restriction.
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White Papers |
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What is process characterization?
EXPUTEC
Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
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Industry Events |
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ELRIG Drug Discovery 2019 – Looking Back to the Future
5-6 November 2019, ACC, Liverpool
Now in its 13th year, ELRIG’s flagship conference Drug Discovery 2019 will take place at
ACC in Liverpool.
This year’s focus, ‘A Look Back to the Future’ is planned to include plenary introductions
assessing how we got to where we are now and setting the challenges for discovering the
drugs of the future. These will be followed by cutting edge talks and examples of new
directions in drug discovery.
Our scientific programme will feature over 40 world-class speakers with 6 main session
tracks. In partnership with key academic and charitable groups, we will also run joint
disease and biology-oriented tracks focusing on the basic sciences that underpin
successful drug discovery.
More info >> |
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