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PUBLICATIONS

Autumn 2021

   
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Richter-Helm – The CDMO to Match Your Needs

Richter-Helm

One step ahead – biopharmaceutical production capacity enlargement
 
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News and Press Releases

Global pharma industry gathers at CPhI Worldwide 2021 as surge in partnering expected in 2022

Over 25,000 online and 23,000 in person attendees at the world’s largest pharma trade exhibition. CPhI Worldwide (9-11 November, 2021), which held its first in-person event since 2019, hosted the global pharma community at the Fiera Milano, Milan, welcoming exhibitors and attendees from 146 countries.
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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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