PharmDev Innovations

Client Portfolio

  • Small start-ups in virtual environment
  • Medium-size pharmaceutical companies
  • Some of the global top 20
  • Generic manufacturers
  • Importers and exporters
  • CMOs (Contract Manufacturing organisations)
  • CROs (Contract Research Organisations)
  • Equipment providers
  • IT providers to pharmaceutical industry
  • Patent attorneys
  • Investors
  • Headhunters / HR consultants
  • Event organisers
  • Architects

Selected projects (anonymised)

  • 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
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