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

Referenzen

Referenzen

Kundenspektrum

ausgewählte Referenz-Projekte (anonymisiert)

Anzahl Beratungsprojekte

Länder, aus denen die Kunden stammten

Eigene öffentliche Trainings-Veranstaltungen (je 6 Vorträge)

internationale Einladungen zu Vorträgen

Anzahl Patente, Marken und Gebrauchsmuster seit 1985