Referenzen
Kundenspektrum
- kleine start-ups in virtueller Arbeitsumgebung
- mittelgroße pharmazeutische Unternehmen
- einige der globalen Top Pharma Unternehmen
- Generika Hersteller
- Auftragsforschungsinstitute (CRO)
- Importeure
- Lohnhersteller (CMOs)
- Anlagenbauer
- Softwarehäuser (mit Pharma Schwerpunkten)
- Patent Anwälte
- Investoren
- Personalberatungen
- Seminar-/Kongress Veranstalter
- Architekten / Bauplaner / Ingenieure
ausgewählte Referenz-Projekte (anonymisiert)
- Switzerland headquartered big multinational company – Business Process Analysis & Optimisation in Pharmaceutical Development
- US headquartered major multinational pharmaceutical company – advising to regulatory particularities in clinical supplies manufacture
- German generic manufacturer – setting up a new company-wide multisite structure of GMP policies and SOPs
- Swiss generic manufacturer – advising on GMP compliance for clinical supplies manufacture of a new product development project for inhalation, acting as contract QP
- German API manufacturer – GMP GAP analysis and trouble-shooting after adverse inspectional findings
- Turkish big generic manufacturer – in-house trainings on pharmaceutical development (formulation, technologies, QbD) and development GMPs
- Indian generic manufacturer – Audit and assessment of GMP compliance for import (of IMPs) purposes to EU
- Polish generic manufacturer – advising on GMP issues in the context of a new building project including development activities
- German generic manufacturer – Audit, GMP Assessment and proposals for improvement after adverse inspectional findings
- Germany headquartered big multinational company – investigating currently practiced business processes along the GLP-GMP interface and proposals for improvement and simplification
- Germany headquartered big multinational company – numerous expert reports on very special international GMP and regulatory requirements for manufacture, labelling and import of IMPs
- Sweden headquartered international software company – Advising on particular requirements of pharmaceutical industry with regard to application of Software as a Service principles
- Switzerland based international biotech company – advising on particularities of IMP labelling for international clinical studies
- Germany based start-up company – advice and active involvement in oncology development projects (pharmaceutical development, formulation, contracting out, GMPs, regulatory etc.)
- Germany based affiliation of a german multinational company – GAP analysis, advice and reporting of findings after adverse inspectional findings
- US headquartered, major multinational pharmaceutical company – evaluation, selection and pilot facilitation of an MES system to support the global clinical supply chain
- US headquartered, major multinational pharmaceutical company – long-term strategic analysis of manufacturing and sourcing activities to support clinical operations at their three global sites
- Germany headquartered, global pharmaceutical company – evaluation of potential scenarios for the selection and implementation of a MES system to support the clinical supply chain
- Germany headquartered, global pharmaceutical company – analysis and documentation of current As-Is processes in pharmaceutical development, clinical trial supplies and the quality control unit to identify areas for standardisation and/or re-engineering, and introduction of performance measurement by defining and implementing appropriate KPIs according to the balanced scorecard approach
- US headquartered, globally active clinical trial supplies contract packager – market survey on the future outsourcing practices of major pharmaceutical companies
- IT systems for investigational medicinal products – evaluation of different software vendors providing MES systems for the IMP market
- Decision support on business strategies of an equipment manufacturer: becoming a pharmaceutical contract manufacturer or not
- Decision support for a clinical supplies service provider: strategic site assessment for further acquisition
- Decision support for a clinical supplies service provider outside EU: strategies for acquiring EU customers including planning of a completely new facility within EU
- Workflow optimisation with a clinical supplies service provider
- Alignment of structure with a clinical supplies service provider in order to better comply with international GxP regulations
- Supporting an IT service provider to get familiar with GMP regulations for software validation and acting as an expert interface between a big international customer and the IT service provider during negotiations about functionalities and validation requirements for a customized MES for clinical supplies preparation (RFPs etc.)
- Advising a big international excipients manufacturer about potentials and pitfalls when entering the business area of pharmaceutical contract manufacturers
- Clinical trial medication management of several big multinational long term clinical trials
- Development of IT supported barcode-controlled labelling system
- Optimisation of the clinical supply process (Quality, Time and Cost)
- Integrated QA system to support and improve the clinical supply process
- Installation of a planning and co-operation concept between clinical and pharmaceutical development
- Training of clinical monitors and CRA`s to understand the details and necessities of the clinical supply chain, forecast, planning, communication and co-operation
Hier einige unserer Leistungsdaten aus den letzten Jahren:
60
Anzahl Beratungsprojekte
13
Länder, aus denen die Kunden stammten
60
Eigene öffentliche Trainings-Veranstaltungen (je 6 Vorträge)
210
internationale Einladungen zu Vorträgen
110
Anzahl Patente, Marken und Gebrauchsmuster seit 1985
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