Pre-selected consultants
for Chiesi
At Medicologic we take great pride in providing top-class consultants to the medical industry. We are partners with some of the most skilled consultants in the industry – setting the level of standards and deliveries as high as possible.
In this consultant-portal, we have selected a line of 70+ consultants with potential interest for the projects and tasks at Chiesi.
Qualification and Validation (ID1020)
Competences:
- Qualification and validation (process/method/software).
- Risk Management.
- Process validation.
- Software and Method validation.
- Equipment qualification.
- Six Sigma (trained master black belt).
- Applied statistics.
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Regulatory Affairs & Project Management (ID1057)
Competences:
- Project Management, R&D
- Design Controls, R&D
- FDA approval process (PMA, De-Novo)
- Technical / regulatory writing
- Implants and Biocompatibility
- Sterile barrier systems including sterilization
- Stability (shelf life) / Transportation
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Senior Consultant HFE/UE Medical Device (ID1034)
Competences:
- Senior Consultant HFE/UE Medical Device
- Directed international teams in usability projects
- Ensured regulatory compliance with FDA and EU rules
- Performed uFMEA and Known Use Problems analysis
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Principal Advisor Pharma Development (ID1046)
Competences:
- More than 30 years of experience from the pharmaceutical industry hereof 14 years’ experience from RA CMC.
- Managerial experience within RA CMC.
- Writing of CTA/INDs for clinical trial applications for Phase I-III.
- Experience with Q&A phases for CTA/IND/NDA/BLA/MAA approvals.
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Human Factor Engineering & Industrial Design (ID1072)
Competences:
- Human Factors Engineering:
End-to-end expertise in strategy,regulatory-alignedSOPs, tool-implementation, and team capability development for medical devices. - Formative & Summative Evaluation:
Planning, Execution and Reporting - People/Team Leading/Management
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Drug Delivery Device Development (ID1073)
Competences:
- Project Management of delivery device development
- Creation of DHF within applicable QMS and Standards
- Due diligence of Drug delivery device and assets acquisitions
- R&D Leadership, strategy and organization
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Toxicology and Biosafety (ID1001)
Competences:
- Regulatory toxicology and product safety.
- Biological Evaluation Report.
- Clinical Evaluation Report.
- Medical Writer.
- Biological Evaluation Plan.
- Toxicological exposure and safety assessment.
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Clinical Evaluation and Biosafety (ID1002)
Competences:
- Risk analysis and safety assessment.
- Clinical evaluation.
- Multi-disciplinary project management.
- Post-Market Clinical Follow-up (PMCF) plan and reports.
- Strategic planning and execution of activities supporting industry board goals.
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Clinical Evaluation and Biosafety (ID1076)
Competences:
- Digital Compliance (ISO 27001, GDPR)
- Quality systems implementation
- Experience compliance adviser in ISO standards and GDPR
- Strong people leader
- Trained as Data Protection Officer and Information Privacy Manager, Lead Implementer ISO 27001:2022
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QA Expert with experience in regulatory affairs (ID1007)
Competences:
- Project Management.
- Executive Management, Strategy.
- Quality Management Systems ISO 9001, ISO 13485.
- Design Control and MDR transition.
- Clean Room, Health and Hygiene and ETO-Sterilization.
- Process-and sterilization validation.
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Senior QA & Compliance Expert (ID1033)
Competences:
- Audit Process Management.
- Inspection Readiness.
- Active & Certified Lead Auditor; external/internal audits.
- Gap Analyses Expert.
- Root Cause & Investigations SME.
- Quality Management | QMS elements.
- Supplier Quality Management.
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Senior QA Consultant and Principal Advisor (ID1077)
Competences:
- ISO 13485:2016, ISO 9001, MDSAP MDR (EU 2017/745) 21 CFR Part 820 (QSR/QMSR), Part 4 Regulation of Combination Products
- Management Representative and Person Responsible for Regulatory Compliance
- Data-driven QMS improvement, through robust CAPA planning
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Troels Keldmann - Consultant ID: ID1015
Principal Advisor – Medical Device Drug Delivery (incl. inhalation & respiratory devices)
Education: M.Sc., Ph.D. Innovation + MBA
Troels Keldmann has over 25 years of experience in pulmonary and nasal drug delivery, including respiratory disease-focused inhalation devices developed in close collaboration with pharmaceutical companies and contract manufacturers. He has led user-driven inhaler innovation and device-strategy programs, translating clinical and patient needs into novel & commercially relevant solutions. His combined expertise in inhalation technology and pharma-side development makes him a strong asset for advanced respiratory drug-device projects.
Contact
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com
Know-how, skills and mindset
At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.
Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.
Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.
We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.
The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.