HWI ANALYTIK Laboratory Services, Reference Standards and Pharmacovigilance

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.

Contract laboratory pharmaceutical services

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:

• Method development and validation using state-of-the-art chromatographic separation techniques such as HPLC, UHPLC and GC
• Identity testing and assay testing
• Purity testing, including forced degradation studies in order to evaluate the degradation pathway, mechanisms and development of chromatographic methods for determination of genotoxic impurities
• Identification of unknown impurities using LC-HRMS and LC-NMR
• Isolation, synthesis and complete characterisation of impurities
• Isolation and selection of analytical markers for herbal medicinal products
• Extractables and leachables studies including testing of packaging materials required by the regulatory authorities
• In vitro dissolution testing (medicinal products, medical devices) with a focus on discriminatory characteristics of the procedure. Assessment of data for the bioequivalence studies to be performed (f2 similarity) for generic products
• Stability studies: conducting of stability testing of drug products, medical devices and drug substances. Comprehensive capacities for storage including controlled substances

Pharmaceutical reference standards compliance package

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

Customised reference 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.

Advantages to using HWI’s reference standards programme

Further major advantages of HWI reference standards include:

• Easily manageable standards: the HWI powder standards that are supplied have good flowability and crystallinity, which enable perfect handling
• Portioning and packaging: our reference standards could be bottled under inert gas in portions for analysis and packaged in leak-proof aluminium bags as secondary packaging. This is an optimum protection from external influences over a very long storage period under extreme storage conditions
• Transport and distribution: HWI takes over the global ‘just-in-time’ transport of the reference standards in substance-specific packaging, thus ensuring a safe delivery of the reference standards
• Storage: HWI stores all reference standards under controlled climatic conditions in accordance with GMP requirements over the requested period of use, and supplies standard portions according to the just-in-time policy
• Retests: HWI performs retests and uses validated test methods that have been developed for the respective standards. Consequently you have no costs for transferring and establishing test methods

GVP-compliant pharmacovigilance services

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:

• Adverse reaction reports (ICSRs, SUSARs)
• Periodic reports (PSURs/PBRERs, DSURs)
• Risk management plans
• Quality assurance systems
• Revision of the pharmacovigilance system
• Assuming of responsibilities (EU-QPPV, stufenplanbeauftragter, information officer)
• Pharmacovigilance system master files (PSMF)
• Pharmacovigilance system audits
• CTD modules 1.8, 2.4 – 2.7, SmPC, IB
• Submission of information on medicinal products to the EMA (XEVMPD)
• Post-authorisation pharmacovigilance
• Pharmacovigilance in clinical trials
• Toxicological consultancy in pre-clinics, safety and drug registration or authorisation, expert reports
• Environmental risk assessment reports (ERA) on medicinal products

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.

Medical services provided by Pharma Solutions Partners

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:

• Sercona in Appenweier
• HWI ANALYTIK in Rülzheim and Tübingen
• i.DRAS in Planegg/Martinsried
• SR Pharmasolutions in Hong Kong

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:

• All regulatory services for API´s (DMF, ASMF, CEP), veterinary medicinal products and human medicinal products during development, registration and life-cycle
• Filing and assessment of technical documentations for medical devices class III; support for clinical development and testing; support in classification issues
• Filing of CTD documentations for the quality part of drug-device combination products

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.