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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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BioIVT Launches Dissociated Tumor Cell DTC Product Line to Advance Oncology Research
Westbury, NY – Sept. 6, 2018 – BioIVT, a leading provider of research models and services for drug development, today announced the addition of a dissociated tumor cell (DTC) product line to its immunology portfolio.
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White Papers |
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Smaller, Smarter, Electronic, Connected: The Next Generation of Drug-Delivery Devices
Phillips-Medisize
An exciting trend in drug delivery is underway: the movement toward smaller, smarter, wirelessly connected electronic devices that allow patient-administered therapy. Inspired by the technological advancements driving the consumer electronics market, new methods for drug delivery show great promise for all stakeholders. Patients wishing to claim more autonomy over their drug regimens, caregivers and medical professionals wanting to more closely monitor drug compliance, health insurance organizations looking to keep costs down, and developers of pharmaceutical products interested in conducting better managed
clinical trials can all benefit from these novel, next-generation technologies.
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Industry Events |
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Pharma and Device Packaging and Labelling West Coast 2018
27-28 November 2018, Burlingame, CA
The second edition of the Pharma and Device Packaging and
Labeling West Coast was a thought-provoking two days of engaging presentations,
discussion and networking.
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