Competence: Our Reference Standards Package for your Benefit
The reference standard concept from HWI offers every pharmaceutical company the required reference standard of a suitable quality at an attractive price-performance ratio.
Laboratory Services, Reference Standards and Pharmacovigilance
Rheinzaberner Straße 8,
76761 Rülzheim,
Germany
HWI ANALYTIK was founded in 1991 and, with its core competencies in the fields of laboratory services, reference standards and drug safety, offers a broad product portfolio of pharmaceutical services. All work is performed in compliance with GMP, GLP and GVP in pharmacovigilance.
We provide our expertise across all types of analytic work in the fields of development, quality control and stability testing of active ingredients, excipients and medicinal products, as well as for pharmaceutical-like products and medical devices. Experienced project leaders take care of our clients’ projects together with 40 employees in our laboratories in Rülzheim and Tübingen.
Laboratory services include:
Our concept offers every pharmaceutical company the required reference standard of a suitable quality at an attractive price-performance ratio. We have more than 20 years of experience in producing, purifying, qualifying and supplying pharmaceutical reference standards. With this expertise we are your perfect partner in the full management of your standards
We also offer a selection of customised reference standards for specific applications and procedures.
R&D standards are tested using chromatography and spectroscopy, and are supplied along with a batch-specific certificate of analysis.
Ident-purity standards are provided along with proof of identity, documented chromatographic purity and a batch-specific certificate of analysis.
Assay standards for pharmaceutical quality control are supplied by HWI as primary standards or working standards (derived from the primary standards). The identity and assay of working standards for assay determination are derived from extensively verified primary standards.
Further major advantages of HWI reference standards include:
With our pharmacovigilance services we enable you to concentrate more closely on your core processes and strengths.
We help you meet all pharmacovigilance requirements in accordance with GVP. Services offered include the optimisation and implementation of processes, creation of compulsory reports and specification documents.
We provide pharmacovigilance services including consultancy, compilation and management of documents, system-implementation, quality assurance and training:
HWI has a comprehensive pharmacovigilance system with EU-QPPV, EV-registration and PSMF. Therefore, we can manage your applications for drug registration / authorisation and maintain your medicinal product throughout the whole life-cycle.
The company group services cover the entire lifecycle of medicinal products, medical devices and other related products. The consortium appears on the market as Pharma Solutions Partners. This comprises the following companies:
i.DRAS GmbH is an affiliated company to HWI ANALYTIK GmbH. i.DRAS is a specialised service provider for regulatory affairs and contract testing of API´s medicinal products, medical devices and drug device combination products.
This may cover:
Sercona GmbH was founded in November 2008 as a subsidiary company of the HWI ANALYTIK GmbH. Sercona supports its clients in development of new products, improvement of existing ones, generic development or development of herbal medicinal products. Sercona provides comprehensive support in the pharmaceutical development of different formulations.
The reference standard concept from HWI offers every pharmaceutical company the required reference standard of a suitable quality at an attractive price-performance ratio.
Whether you wish to develop new products, improve existing ones or optimise quality, Sercona provides comprehensive support in the pharmaceutical development of different formulations.
We can support you across all regulatory activities. Our range of services covers development projects, full generic or bibliographical applications for marketing authorisation, traditional registration, national and international procedures, including variations and renewals, dossier updates and the extension of pharmaceutical product lines.
Comprehensive laboratory and consultancy services for active ingredients, medicines and pharmaceuticals-like medical devices: these are our core activities at HWI.
Sanofi, a global healthcare leader based in France, is expanding its biologics plant in Belgium, to further develop its manufacturing and commercial production capabilities.
HWI ANALYTIK has released a series of white papers on the services it offers in the pharmaceutical industry.
Rheinzaberner Straße 8
76761 Rülzheim
Germany