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 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.
• 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.
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.
• 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.
• 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.
• 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.
The company's first approved medical device app
Establish processes to handle medical software
Collaboration with software experts
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
Business advisor for leading medical device and pharma companies
Project management of development projects
User requirement analysis and business plans
Contact and contracts with CROs/Academic institutions
Review of protocols and reports
Compilation of results and statistical assistance
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
Identification and evaluation of market trends
Identification and execution of verification activities
Evaluation and development of test methods including statistical and laboratory support
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
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.