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PharmDev Innovations
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Referenzen

Kundenspektrum

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  • 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)

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  • 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:

Mehr als ...

60
... Beratungsprojekte

 

Uns haben Kunden vertraut aus mehr als ...

13
... Ländern

Wir durften Teilnehmer begrüßen bei mehr als ...

60
... Trainings

Wir wurden eingeladen zu mehr als ...

210
... Vorträgen

Es entstanden seit 1985 mehr als ...

110
... Patente