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 to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
Successfully developed and validated analytical methods can reduce overall turnaround times spanning from pre-clinical right through to commercial release, with a well-developed method underpinning a robust product.
Starting with the end point in mind, methods should have the desired flexibility built in during the early stages to allow easy translation from API to DP, thus potentially reducing costs throughout the product life-cycle.
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