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Pharmaceutical Manufacturing and Packing Sourcer
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Well known as a sugar replacer in the food industry, isomalt is also highly suitable for a wide range of pharmaceutical applications.
Pharmaceutical products must meet increasingly exacting requirements; it is not enough for a medication to have the desired effect. Products also require optimal quality in taste, texture, appearance, shelf life and packaging. This applies all the more to the highly competitive market of OTC products and dietary supplements.
The excipient also plays a key role in pharmaceutical products. It must provide the perfect means of delivery for the actual active ingredient while giving the product ideal characteristics. The main requirements are compatibility, stability in terms of physiological and chemical properties (non-ageing), neutrality in taste and appearance, and the ability to enable precise dosage. Furthermore, good organoleptic properties and added benefits like calorie reduction, tooth-friendliness or low glycemic response are important, especially where consumers or patients can choose between different products with comparable effect. Generally speaking for pharmaceutical manufacturers, the safety and availability of the excipient is crucial.
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News and Press Releases |
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Everything Genetic launches Next Generation Sequencing service as part of its public-private partnership with Berkshire and Surrey Pathology Services
NANTWICH, CHESHIRE and GUILDFORD, SURREY, NOVEMBER 2022. Everything
Genetic, a fast-growing UK business offering genetic testing services
for the diagnosis, prevention and treatment of a range of cancers, has
partnered with Berkshire and Surrey Pathology Services (BSPS), an NHS
Pathology Network, to provide Next Generation Sequencing (NGS) services
to healthcare professionals and customers across the UK.
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White Papers |
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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 developers 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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