IN NEED OF EXPERT HELP?
Pharma4ever specializes in consultancy work for pharmaceutical, biotech and medical device companies
What we can do for you
Production setup
- Implementation of work processes
- Creation of production documents (SOP’s)
- Training of operators
Optimization of existing production equipment
- Systematic root cause analysis
- Shutdown planning
- Implementation
Project Management
- Equipment implementation
- Production facilities
- Launch of new products
Equipment specification
- User requirement specifications
- Design specifications
- High level mechanical and automation knowledge
Equipment selection
- Systematic tools for supplier selection
- Major vendor knowledge worldwide
- Best choice based on the newest technology and stability
Equipment validation
- FAT/SAT
- IQ/OQ
- PQ
Medical Device QA
- Medical Device documentation – Design Control
- Risk Assessment Performance
- Medical Device Quality expertise
Medical Device Regulation
- Medical Device Regulatory expertise
- Auditing expertise ISO 13485
- Quality Management Systems
- Regulatory clarification
- Authority Approval
- Documentation Level
- Basic Quality Requirements
- EU MDR
- US FDA
- MDSAP
- cGMP
- QMS structure
- Procedures
- Instructions & Templates
- Training & Internal audit
- Development planning
- Design Input
- Design Output
- Design Verification & Validation
- Design Transfer
- Requirement Specifications
- Validation Plans
- Risk Assessment
- Validation Protocols
- Validation Performance & Reporting
- Statistical Process Control (SPC)
- Statistical Test and Analysis
- Sample Size Determination
- Acceptance Sampling
- Design of Experiments
- Reliability/Durability Estimation
- Courses
- Individual needs
- Education of internal auditors
- Biological Evaluation
- Clinical Evaluation
- Implementation
- Sourcing – Supplier Identification
- Sourcing – Supplier Approval & Maintenance
- Purchasing
- Desk-Top audits
- Gap Analysis
- Regulatory Clarification
- Chemical and Analytical Support
- EU IVDR
Why choose
Pharma4ever?
Reason one
We help our customers reach the project goals and achieve outstanding quality within the agreed timeframe and budget.
Reason two
We are involved from the beginning to the end of any project, thereby ensuring efficiency and quality in every aspect.
Reason three
Our experienced employers are capable of working independently and take responsibility in order to get the work done.
Our
Clients
Pharma4ever’s employees have assisted several pharmaceutical, biotech and medical device companies companies in Denmark in a vast array of projects.
If you find our work interesting and want to know more
