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Research & Development


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Research & Development


emendo Research & Development ApS

A part of the emendo Group

emendo R&D provides highly qualified consulting services which combine the lean tool box and project management with deep scientific and regulatory knowledge to empower R&D organizations within pharma and medical devices.



About emendo Research & Development

Our consultants have diverse technical backgrounds, but common for all is that we thrive to gain deep industry expertise and are dedicated to find the right solutions to technical matters. With profound scientific backgrounds, we assist R&D departments in creating better and more innovative solutions to technical opportunities by sharing our broad knowledge, systematic methodology and comprehensive network gained from many years in the business. 

emendo R&D successfully assists leading pharmaceutical and medical device companies in achieving their project goals within R&D – with continual focus on best practices, sustainable solutions and always putting the needs of our clients first.

 

Our key areas, with a proven track record, include (but are not limited to)

  • Scientific consulting
  • Project management
  • Method validation
  • Design control
  • Contract research
  • Technology scouting 

What we do


What we do


What we do

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Project Management

• Project Plan and Coordination
• Budget and Resource Control
• Risk Management
• Quality Assurance
• Project Process Tracking and Status Reporting

Scientific Consulting

• Medical Device Industry
• Pharmaceutical Industry
• Biotechnology Industry


Method Validation

• Method Review
• Regulatory Compliance
• Validation Parameters
• Data Handling/Analysis
• Planning and Coordination
  of Validation Activities

 

Design Control

• Development Plan
• Risk Analysis
• Design Input and Output
• Design Validation (Protocol
  and Reports)
• Planning and Coordination
  of Validation Activities


Contract Research

• Strategic Planning
• Test Support/Clinical Trials
• Clinical Monitoring
• Data Management and
   Biostatistics

Technology Evaluation

• Identification of Needs and
  Gaps
• Market Research/In-Depth
  Knowledge of Market Trends
• Expert Interview
• Capability Assessment and
  Opportunity Evaluation
• Stakeholder Analysis


 
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Our Good Stories


Our Good Stories


Development of Mobile Medical App

How it became a Good Story: Design process was treated like any other medical device

 

Extractables and Leachables (E&L) testing

  • Design of E&L studies
  • Setting up contracts with CRO
  • Review of protocols and reports
  • Compilation of results for tox assessment and
    facilitation of tox assessment and concluding on studies
  • Project management with external partners
  • Coordination and systematic approach
  • Material science

Development of medical devices with antimicrobial technology

Morten has many years of academic research experience combined with excellent business understanding and regulatory knowledge

 
  • Business advisor for leading medical device and pharma companies
  • Project management of development projects
  • User requirement analysis and business plans
  • Technology scouting/evaluation
  • Clinical evaluation/investigation
  • Contact and contracts with CROs/Academic intitutions
  • Review of protocols and reports
  • Compilation of results and statistical assistance

Revitalization of global R&D

A large medical device company had lost a significant market share
 

  • Facilitation of gap-analysis, competitor overview and market analysis
  • Scientific assistance to user requirements, marketing and business case
  • Scientific advise for technology sourcing, patents and in house testing
  • Support to selection of lead candidates
  • Planning of clinical evaluation and investigation
  • Scientific support to marketing strategy 


Designing Medical Devices Correctly

Design verification - the core element to the delivery of any successful medical device

 

  • Identification of verification activities
  • Thorough review of essential requirements to be verified
  • Evaluation and selection of test methods (test plan development)
  • Development of new in-house test method
  • Review of test protocols
  • Statistical assistance
  • Overall preparation of real time and accelerated stability testing
  • Detailed planning and coordination of verification activities 
  • Stakeholder management 
  • Verification report

Verifying Suitability of Test Methods

A large medical device company needed support to validate R&D test methods
 

  • Method review
  • Identification of validation activities (full/partial validation)
  • Evaluation and selection of relevant validation parameters (validation plan development)
  • Support to establish validation criteria
  • Data handling and statistical assistance
  • Method improvement assistance 
  • Detailed planning and coordination of all validation activities

 


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Our Team


Our Team


emendo Research & Development

Morten Alhede

Morten Alhede

Managing Partner
MSc Biotech Engineering,
PhD in Medical Microbiology


+45 23 74 05 33

→ Download Business Card

→ Email Morten

Kristine Pagh Laursen

Kristine Pagh Laursen

Partner
MSc Biomed Engineering


+45 23 74 06 76

→ Download Business Card

→ Email Kristine

Sengül Zulferovska

Sengül Zulferovska

Consultant
MSc Biotech Engineering


+ 45 21 31 93 10

→ Download Business Card

→ Email Sengül

Jacob Christian Hansen

Jacob Christian Hansen

Consultant
M.Sc. Chemistry
Ph.D. Pharmaceutical Sciences


+ 45 51 29 71 07

→ Download Business Card

→ Email Jacob Christian


Board of Directors

Finn Hunneche


Co-owner

Anders Arnum Jensen

Co-owner
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Morten Alhede


Co-owner

Kristine Pagh Laursen

Co-owner
 

We are proud members of the emendo Group