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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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ACG CAPSULES SET FOR EUROPEAN EXPANSION
ACG Capsules, one of the largest manufacturers of empty hard capsules (part of the ACG Group), demonstrated its commitment to European expansion by completing a series of appointments across the region.
More info >> |
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White Papers |
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Wrap Around Label - A Lot of Content in a Small Space
Faubel & Co. Nachfolger GmbH
One of the world’s largest contract research organizations for the
planning and conducting of clinical trials was faced with the challenge
of accommodating many different national languages on an inhaler. The
inhaler was then to be distributed in 47 countries. Due to the impressive quality and
reliable collaboration, the organization commissioned Faubel with
finding the optimal labeling solution for the inhaler.
More info >> |
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Industry Events |
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SMi presents the 13th Conference on ADMET
9-10 July 2018, Holiday Inn Kensington Forum, London, UK
SMi is delighted to announce the 13th annual ADMET
conference returning to London to explore the optimisation of ADMET modelling techniques, preclinical
DMPK applications and development of biopharmaceuticals.
More info >> |
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