Capabilities
Change Management and Innovation
Shifting Change Management to foster Innovation.
Boost your company Value Creation and improve your Patients Journey.
75% of organizational change projects fail to achieve their objectives. But why?
Transformation is a business imperative, even for market leaders.
Yet common obstacles and challenges are known: unclear objectives and milestones and insufficient engagement from senior management in support, training and culture.
We support companies building a Change Culture from top to bottom.
Clinical Trials
Reduce the time and cost of getting new medicines to patients
Prioritizing Patient Safety.
We offer Lean and Agile solutions which will meet your timelines for clinical trials whether you apply in the USA (FDA) and in Europe (EMA).
We can support Sponsors with a wide range of services thanks to our network of clinical experts who can address the different laws across the several European jurisdictions.
Our area of expertise covers:
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Clinical trial's authorisation procedure
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Good Clinical Practice
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Safety Reporting
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Clinical Trial Data Transparency
Our capabilities include
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Quality Assurance & Compliance
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Regulatory
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Pharmacovigilance
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Development
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Medical
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Statistical
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Market Access
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IT & Data Management
Companies Set-Up
Quick and Efficient.
We are a One-Stop Shop for companies to set up subsidiaries in Switzerland and Europe.
The prerequisite for a life sciences company to request the Marketing Authorisation Holder (MAH) with the European Medicines Agency (EMA) is to have a permanent establishment within a country of the European Union.
The EMA requires proof of establishment and failing to comply can delay the application.
Of course, it is possible to appoint a representative, however the MAH remains responsible for assuring all the obligations imposed on MAHs by the European legislation and by national laws, as applicable.
It is therefore very important to think carefully where to establish first, as it will be determinant for the future of the European operations, including the companies and tax structure.
Life Science Services can support you with the following:
Due Diligence
Based on your business type, strategy and objectives, these are some of the elements we will consider before starting the incorporation of any subsidiary:
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Substance and value chain creation analysis
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EMA submissions transferts
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Elaboration of a suitable tailor-made tax business model including intellectual property aspects (if any)
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Tax opportunities and tax risk analysis.
Incorporation
You can set up a company in no more than 3 working days, and for a capital cost starting at EUR 100.
The requirements vary depending on the country. However, the EU encourages all countries to meet common targets for helping to set up new companies.
People Resources
We provide support to your international employees and team members under various forms:
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Payroll company
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Interim management solutions
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FTE for a limited period of time
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Management consulting solutions
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Project managers & advisors to manage and mentor your projects
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Market Access
Optimise market access for your products
Get the right price, for the right patients, at the right time.
Understanding the payer requirements, and how the reimbursement and funding system work in each market, is critical for how you develop your product, what price you can get, for which patients it will be reimbursed and when it will be accessible to them.
Value propositions, payer research, evidence gap analysis, and health economic models are important tools to support commercial decision-making as well as the clinical development program.
Our approach is to focus on three steps in the Value Creation for your products.
Value
Identification
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Market access landscape/analogue assessments
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Payer research/advisory boards
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Early health economic modelling
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Early value proposition
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Price assessment/commercial opportunity
Value Generation
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Evidence gap analysis/evidence generation plan
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Literature reviews
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Input to clinical trial (payer) endpoints
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Statistical analysis plan/treatment comparison
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Value message testing
Value Communication
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Global value story and dossier
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Global health economic model
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Global pricing strategy and launch sequence
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Internal launch preparation
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Health Technology Assessment (HTA) submission
Our capabilities include
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Health Economic Modelling
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HTA
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Disease Models
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Model Implementation
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Validation
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Budget
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Impact Healthcare Decisions
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PAYERS
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Providers
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Clinicians
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Patients
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Market Access & Reimbursement
Operations
Improve Patients Journey through better Operations.
Digital and analytics are reinventing Operations for more efficience and effectiveness.
Speed, quality and cost efficient.
As supply chain is facing more volatile and complex situations, the expectations have never been so high to bring products to Patients faster and safer.
How to give rise to "the Operations of the future"?
Data integration and analytics are part of the tools to the promised land.
Quality
Quality with a big Q.
Prioritizing Patient Safety.
Whether you are an established company or a growing start-up in Pharma or Biotech, we help you achieve your Quality targets.
From Phase I to commercial readiness, we support you achieve your targets in:
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Design of Quality Management Systems (QMS)
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Inspection readiness programs and mock inspections
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Investigations, CAPAs, Risk Assessments
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Liaising with Health Authorities
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Due diligence and audits (routine/ad hoc)
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SOPs and Technical Agreements and Documentation
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QP/FvP services
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Internal training programs, coaching and Quality KPIs
Our Commitment to you
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Agile
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Tailor made
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Best-in-class solution
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Reliability
Tax (Direct & Indirect)
We make your tax (savings) great again!
With over 60 jurisdictions, we offer a unique, strategic and global experience in tax.
We deliver Best-In-Class tailor made solutions with a 360 degrees approach for direct and indirect taxes.
Thanks to our expertise and our cross-functional approach, we are able to design your tax strategy and turn it into positive outcomes, without any impact to your operational structure.
Opportunity
Let you guided for being compliant and maximize your global tax footprint.
Mission
We are the custodian of your tax policy and we design the most optimized and compliant solution for your organization.
Market Focus
EMEA – APAC - AMERICA
Competitive Advantage
We transform your Tax from a cost center into a profit center. Furthermore, because of future policies, your good tax practices will become a positive marketing advantage.
Ownership
Our model is top to bottom and every employee and third party involved contribute to the Tax model.
Future Returns
Compliance and successful global tax optimization and savings!
