Pharma
At Medicologic we take great pride in providing top-class consultants to the Pharma industry. We have shaped a range of services to fit the needs of our clients and accommodate most potential skills and flexibility needs.
Our services within Pharma:
In-Housing
With our in-housing service you get full controll of budget, hour-usage and planning tasks with our consultant being present at your office on a everyday-basis.
MDR- & IVDR-Transition
At Medicologic we are ready and able to assist our clients through the new Regulation, and our consultants are both experienced and highly skilled within MDR and IVDR.
Try & Hire
Our experiences in recruiting and matching consultants with our clients’ needs and projects have tought us key insights in recruitment, for the benefit of our clients.
Our consultants within Pharma:
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.
Senior Clinical Compliance Expert (ID1003)
Competences:
- Clinical compliance (MDD).
- Clinical compliance (MDR/IVDR).
- Clinical trials and GCP.
- Clinical Evaluations.
- Expert insight within the healthcare sector.
- Business innovation on the basis of science and research.
Validation Specialist, Techno-logy and Chemestry (ID1019)
Competences:
- Lead Validation.
- Senior CQV Engineer.
- Risk Assessment.
- Process and Cleaning Validation.
- QA Validation.
- Quality Assurance.
- CAPA and Compliance.
- Qualification and Validation.
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.
Pharmaceutical and Medical Device Compliance (ID1023)
Competences:
- Engineering projects related to Medical Device Industry.
- Project management, planning and implementation.
- Compliance (Pharmaceutical and medical device business).
- Vendor & contract management.
- Data and trend analysis.
Qualified Person (QP), API release (ID1029)
Competences:
- NC/CAPA Process management.
- Systematic problem solving (Coaching).
- Change request process management.
- Validation Activities (URS, Equipment Qualification, and process Qualification).
- QP (Batch review and product release).
- QMS implementation (procedures/templates)
Senior Consultant Compliance and Management (ID1030)
Competences:
- Project Management.
- Quality Management.
- Medical Device.
- People leadership and management.
- Process mapping.
- cGMP.
- Performance Management.
- Change Management.
QMS & Supplier Quality Expert (ID1031)
Competences:
- Supplier Management.
- Quality Management.
- Audit Management.
- Trained lead auditor/
internal auditor. - Team/Department management.
- Management representative.
- Quality system implementation.
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.
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.
Contact
Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
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