Altran LifeScience Services

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Pharma and Biotechnologies Medical Devices Health Services

Transcript of Altran LifeScience Services

Page 1: Altran LifeScience Services

Pharma and BiotechnologiesMedical DevicesHealth Services

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Altran, global leader in innovation and high-tech engineering consulting with 23’000 employees in over 20 countries, partners its clients in the creation and development of new products and services.

Our Life Sciences division, backed by a network of 1’600 specialists, combines its own expertise with Altran’s unique ability to leverage the most innovative solutions from other areas such as Aerospace, Automotive, Energy or Railway to solve the complex problems facing the Pharmaceutical and Medical Device industries.

Active in Switzerland since 1993, Altran has developed a leading Life Sciences practice. Global knowledge combined with the industry expertise of a local team of consultants enables us to support businesses and suppliers in the highly regulated Life Sciences domain.

�� Embedded Systems / Connectivity

�� Big Data solutions (VueForge™)

�� Digital Health and Mobile Solutions

�� Electronic Document Management

�� Innovation Strategy

�� New Product & Services

Development

�� Technical Market Studies

�� Six Sigma / Lean Manufacturing

�� Project Management Office (PMO)

�� Overall Equipment Effectiveness (OEE)

�� Supply Chain Management

�� Health Safety Environment

�� Qualification / Validation

�� Audit, CAPA, Deviations, Complaints

�� Quality Control

�� WCC Quality Efficiency

�� Facilities, Equipment & Utilities Engineering

�� Process Development

INTELLIGENT SYSTEMS

INFORMATION SYSTEMS

OPERATIONAL EXCELLENCE

INNOVATION MANAGEMENT

REGULATORYAFFAIRS

PROCESSENGINEERING

QUALITYASSURANCE

INNOVATIVEPRODUCT

DEVELOPMENT

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�� Embedded Systems / Connectivity

�� Big Data solutions (VueForge™)

QUALITY ASSURANCE

Quality Management Systems (QMS), Quality by Design, Mock audits, Management of CAPA, Deviations, Complaints, WCC Quality Efficiency

for organisation performance & human errors reduction, .

QUALIFICATION / VALIDATION

Validation Master Plan, Process, Equipments and Utilities Qualification, Computer System Validation (CSV).

REGULATORY AFFAIRS / COMPLIANCE

Ensure Regulatory Compliance and prepare submissions, Management of promotional material.

PROCESS ENGINEERING

URS, Basic and Detailed Design, Installation Management, Commissioning.

INNOVATIVE PRODUCT DEVELOPMENT

Develop products from concept to prototyping including launch in full compliance with Pharma and

Medical Device directives.

INTELLIGENT SYSTEMS

Bring together Embedded & Real-time systems, Sensors, Connectivity and Big Data to enable Internet of Things (IoT).

PHARMACEUTICALS

BIOTECHNOLOGIES

MEDICAL DEVICES

HEALTHCARE

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OPERATIONAL EXCELLENCE

Improve the performance of operations in industrial companies.

LEAN SIX SIGMA

Improve quality of process outputs, Attain cost reductions, Shorten time to market, Waste reduction, Value Stream Mapping (VSM).

PMO (Project Management Office)

Prioritize the project pipeline, Limit risks, Effectively plan and execute complex project in regulated environments.

OEE (Overall Equipement Effectiveness)

Reduce and solve complex production problems using intuitive dashboards.

INNOVATION MANAGEMENT

Manage all the stages of the innovation process, from ideas to launch, using Synectics® creativity methodology and Design Thinking.

INFORMATION SYSTEMS

Move into the digital world with Business & IS applications (BI, SAP, ITQ, ECM) and IS transformation (ITG, EA, Security, and Cloud Services).

DIGITAL HEALTH AND MOBILE SOLUTIONS

Connect Medical device hardware to create e-Health enterprise solutions and enable connected mobile applications.

ELECTRONIC DOCUMENT MANAGEMENT

Consolidate information, Reduce operational costs, Improve Business Process Management (BPM).

NEARSHORING / OFFSHORING

Outsource global projects, from Study phase to Production using Altran World Class Centers expertise from all around the world.

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Pharma Project Management Office (PMO)

ChallengeA nascent PMO achieved some quick wins and now seeks to extend their global offering.

Results��Link strategic vision to project execution.��Evolution to blended PMO with Supportive,

Controlling and Directive model offerings. ��Extend KPIs and Communication

Channels.

Medical Device Combination Product

ChallengePrepare products classified as Class III combination products.

Results���Digital Health enterprise solution with integrated native mobile solutions (tablet and phone).��Usability and Human Factor studies.���Including Patient Reported Outcomes and Payers module.

Biotech Quality by Design Methodology

ChallengeDefine Quality by Design (QBD) practices aligned to new FDA validation procedures.

Results��Validation Master Plan for upstream

process with Critical Processing Parameters, Critical Quality Attributes and FMEA support.�� Acceptance limits set by statistical analysis.�� New Qualification protocols, and reports for

trending and monitoring.

Hospital Centralised Ophthalmic Imaging System

ChallengeCreating a single seamless solution that meets the requirements of all vendor systems.

Results��Fully functional prototype within 3 months.��Unified user friendly interface for all imaging

systems.��Real time access to all diagnostic images

enhances efficacy of treatment and quality of care.

Disdeo - Altran Pr[i]me

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INNOVATION MAKERS

Lausanne Avenue de Rumine 13 1005 Lausanne Tél. +41 58 122 12 34 Fax +41 58 122 12 29

Geneva Quai du Seujet 16 1201 Geneva Tél. +41 58 122 12 50 Fax +41 58 122 12 60

Zurich Hardturmstrasse 253 8005 Zurich Tél. +41 58 122 12 70 Fax +41 58 122 12 90

Basel Steinenring 52 4051 Basel Tél. +41 58 122 12 70 Fax +41 58 122 12 90

[email protected]