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Bioclinica

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Finding the Right End-to-End Safety Solution for Your Needs

With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
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News and Press Releases

Northway Biotechpharma Celebrates 15 Years of Growth and Success

Vilnius, Lithuania, July 16, 2019 ─ Northway Biotechpharma, a leading biopharmaceutical contract development and manufacturing organization (CDMO), celebrates its 15th anniversary today. As a midsized CDMO, Northway Biotechpharma is able to provide flexibility and responsiveness backed by a strong foundation in science and technology. The company focuses on understanding its customers and meeting their specific needs without binding them to one single approach. It is able to react rapidly to unexpected project changes, adjusting timelines, capacities and other activities to meet its customers’ evolving needs. On average, Northway Biotechpharma has 25–30 development projects underway each year, ranging from gene cloning to final drug product manufacturing.
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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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Industry Events

INTERPHEX 2020

15-17 July 2020, Javits Center NYC


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