emendo Research & Development

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emendo Research & Development ApS

A part of the emendo Group

emendo R&D provides highly qualified and GxP certified consulting services. We combine deep scientific and regulatory knowledge with project management to empower R&D organisations within pharma and medical devices.

project ManagementProject Management
scientific consultingScientific Consulting
method validationMethod Validation
design controlDesign Control
contract researchContract Research
technology evaluationTechnology Evaluation
 


 

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

All phases of an innovative development project should be controlled and managed. emendo R&D successfully assists leading pharmaceutical, biotech and medtech companies achieve their project goals within R&D. All of our consultants have succeeded project management courses and thrive to manage innovative projects. We are renowned for being the consultants who always aim high and deliver.

 
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Scientific Consulting


• Systematic problem solving
• Laboratory support and management
• Scientific concept evaluation
• Design of experiment and statistical analysis


We employ people with diverse technical backgrounds, but common for all is that we thrive to understand how things work and 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.

 
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Method Development, Validation and Transfer


• Method Review and Conceptualisation
• Defining Validation Parameters and Acceptance Criteria
• Planning, Coordination and Execution of Validation and Transfer Activities
• Data Handling, Analysis and Documentation
• Regulatory Compliance


Development of robust and reliable methods is essential to ensure consistent results, product quality and compliance. We successfully assist companies in determining the scope of the methods and offer support through all phases from development to validation and transfer. We understand the importance of quality assurance, and we are committed to staying up-to-date with relevant guidelines in order to guarantee that we always offer you optimal validation support.

 
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Design Control


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


It is essential to control the design and development process of medical devices, while keeping track of regulatory requirements. emendo R&D believes in quality by design, and our consultants are deeply experienced in successfully developing innovative medical devices. Design control is our core competency and we understand the importance of controlling the entire process in order to get the fastest and best product to the market - and to do it right the first time.

 
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Contract Research


• Strategic Planning and Management
• Test Support
• Data Management and Statistics


emendo R&D maximizes the output of external work, by assisting companies selecting and setting up agreements with contract research organisations. With our profound knowledge in laboratory testing and clinical investigations, we are able to help you through all phases of your external testing.

 
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Technology Evaluation


• Identification of Needs and Gaps
• Market Research
• Expert Interview
• Capability Assessment and Opportunity Evaluation
• Stakeholder Analysis


Scientific backgrounds combined with solid business understanding and our large network are the cornerstones in our assistance to companies that are either acquiring or licensing new technology. We provide a comprehensive evaluation of the technologies relevant for the given application and relate it to the users’ needs, competitors and the potential market. We recognize the importance of understanding the user and we collaborate with leading experts within user experience and anthropology to create the best and most useful product.

 

Good stories

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Development of Mobile Medical App

Kristine has been project manager for an app development project from concept to launch

  • The company's first approved medical device app

  • Establish processes to handle medical software

  • Collaboration with software experts

 

 

PM: Pharmaceutical development

Sengül and Morten are dedicated project managers able to effectively adapt to the client’s organization and the needs of its employees

  • Project management of development projects with the client in focus

  • Coordination of CMC activities for clinical trials

  • Coordination and preparation of authority filings and inspections

 

 

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

  • Contact and contracts with CROs/Academic institutions

  • Review of protocols and reports

  • Compilation of results and statistical assistance

 

 

Revitalization of global R&D

A large medical device company had lost significant market share. Morten’s research and development experience combined with Finn’s profound business understanding initiated the turnaround in the company

  • Facilitation of gap-analysis, competitor overview and market analysis

  • Scientific support to user requirements, marketing and business case for novel products

  • Scientific advice for technology sourcing, patents and in-house testing

  • Support to selection of lead candidates

  • Planning of clinical evaluation and investigation

 

 

Effective development of novel MEDICAL DEVICES

Kristine, Jacob and Tanguy combine process understanding, regulatory insight and scientific backgrounds in developing successful medical devices

  • Identification and evaluation of market trends

  • Identification and execution of verification activities

  • Evaluation and development of test methods including statistical and laboratory support

 

 

VERIFYING SUITABILITY OF TEST METHODS

emendo R&D support the development, validation and transfer of analytical methods ensuring robustness and regulatory compliance

  • 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

 

emendo Research & Development

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About emendo
Research & Development

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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 assist 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.

 

 

We are proud members of the emendo Group