Services 2017-07-24T21:46:30+00:00

M & A Support

M&A Support: Acquisition, divestiture, or mergers of Companies, Products, or Company assets

We can handle your entire M&A project – be it buy side or sell side – but we also integrate with your project team (internal and external advisors) be it on an individual module (e.g. commercial or technical due diligence), or as senior expert advisors on specific topics.

  • Strategy development
  • Screening of the market environment, target profiling
  • Target identification
  • support of divestures, preparation of teasers/info memos, identification of potential buyers
  • Due diligence and target valuation
  • Negotiation support<
  • Post Merger Integration and action plans
  • Synergy tracking

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fidelio healthcare services

Strategic Management Support

From an elaboration of a vision, through development of a strategy to preparation of a road map and execution of an action plan, we establish strategic plans to defend existing business and to identify future growth opportunities

We can assist you in your full planning cycle, from strategy development to monitoring implementation.

  • Geographic expansion and go to market strategie
  • Business Development and Marketing & Sales with a Focus on B2B
  • Product strategies (differentiated, mature, off-patent)
  • supply and manufacturing strategy, manufacturing network optimization
  • sourcing strategies, make-or-buy decisions
  • R&D strategies
  • Translating strategies into implementation plans and financial plans
  • Optimization of organizational set-up
  • Change management and cultural change
  • Support and monitoring of implementation

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Supply Chain and Operations Consulting

We can create value in optimizing your entire supply chain at different levels. Based on our longstanding experience in project design and execution, our expertise covers a broad range from strategic projects at global scale up to site or department specific enhancement programs:

  • Geographic expansion and go to market strategies
  • Operating and organizational strategies including manufacturing network/foot print optimization
  • Technology and product portfolio analysis and planning
  • Lean management and implementation of process orientation at manufacturing
  • End-to-end supply chain efficiency & sustainability including inventory streamlining and throughput time reduction
  • Footprint Set-up, manufacturing network optimization, supplier network optimization, make-or-buy decisions
  • Product & technology transfer
  • General Project and CAPEX management
  • Strategic Procurement projects

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R&D Management and Regulatory Services

Our team has a proven track record of strengthening the business and scientific aspects of drug product development from concept to commercial launch. We support pharmaceutical and healthcare companies to streamline their R&D teams and processes and to optimize their product portfolio.

  • Our general R&D services cover
  • Technical due diligence of pharmaceutical companies with regards to R&D during M&A
  • Assessment of development organizations and infrastructure and advice for optimization
  • Establishing R&D management tools, reporting structures, KPIs
  • Technical and commercial portfolio assessment
  • Elaboration of proposals for new project initiations
  • Set-up of a continuous risk-based portfolio management process

With our technical background and hands-on approach, we help manage complex development projects, and master pharmaceutical and analytical challenges while keeping track of the relevant regulatory aspects for EU and USA. Our Regulatory services cover

  • Elaboration of development concepts and strategies for drug products and corresponding manufacturing processes up to commercialization
  • Patent landscape evaluation including-freedom-to-operate analysis
  • Establishing and maintaining project reporting structures
  • CMC coordination services
  • Monitoring of manufacturing campaigns (“man in the plant”)
  • Trouble shooting with corresponding gap analysis and root cause assessment
  • Preparation and review of technical documents up to the compilation of the entire registration dossier.

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Quality Management

We can help your Quality function on its way to provide state of the art support for your technical operations. Hands on experience from several turn arounds, FDA readiness projects and efficiency projects provide the basis for sustainable results. Cultural change to transform Quality management into a transparent supporting business partner is the well proven basic principle.

As well we can support you by driving individual projects or initiatives, e.g.

  • KPI implementation
  • Streamlining of documentation
  • Pass through time improvements
  • Inspection readiness preparation
  • QM Software implementation
  • Documentation “right first time”
  • Auditing and Training

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Interim Management

We can help you to fill temporarily vacant management positions with our executive team comprised of highly qualified and experienced leaders. All our interim managers have a long-standing excellent track record in managing a broad range of complex situations. They will immediately take over operational responsibility based on clients’ individual requirements.

We can deliver all areas of our expertise throughout the entire value chain on an interim management basis:

  • Top Executive Roles
  • Overall Supply Chain management
  • Managing Director / General Manager of manufacturing site
  • Head of production
  • Head of strategic procurement for contract manufacturing, production materials
  • Head of Quality Unit (Quality Assurance / Quality Control) / Qualified Person
  • Head of Engineering
  • Head of R&D department
  • Project Manager
  • Continuous Improvement Manager

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OUR CONTACT

Fidelio Healthcare Partners GmbH & Co. KG

Schlosshof 7
D- 82229 Seefeld . Germany
Phone: +49 8152 98 323 – 61
Fax: +49 8152 98 323 – 70

info@fidelio-healthcare.com
www.fidelio-healthcare.com

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