QUALITY Matters
HELPING YOUR PHARMA COMPANY TO SECURE QUALITY SYSTEMS AND PROCESSES
Pharma businesses are heavily regulated and inspected by Health Authorities
Compliant & safe
Keep your company compliant with regulations and ensure safe products for your patients
Actionable frameworks & proven systems
Decades of experience distilled into actionable knowledge improving your pharma development
What we do
Services and courses that suit your needs
Services
- Business Continuity Management and Plans
- Pharma Quality Systems
- Patient Safety
- Audits
- Consultancy for Pharma Investors
- Regulatory affairs
- Clinical trials
Courses
- Audit and Inspection Management
- Good Clinical Practice for Managers
- Structured Emergency Management in Pharma companies
- Structured Quality Assessment of 3rd party subcontractors
- The EU Clinical Trials Regulation (CTR) No 536/2014
- The EU General Data Protection Regulation (GDPR) in clinical trials
Björn Edwall
Pharma Consultant
Björn has more than 30 years of experience in leading positions within the pharma industry at global companies including Novartis and Astra. He has extensive hands-on experience in Quality Assurance, Patient Safety, Clinical Trials, Emergency Management, Regulatory Affairs, Medical Information and Licensing. Björn has also more than a decade’s experience of serving on the Board of Trustees for the Swedish Pharmaceutical Insurance Company. He holds a PhD in Pharmacology from Karolinska Institutet in Stockholm.
Testimonials:
“– I highly recommend Björn who really knows pharma business and is a great person to interact with!”
Jan Lundberg, previous Head of Global Research for AstraZeneca and Eli Lilly
“- For high quality of Regulatory Support, contact Björn“
Janolof Waltersson, Senior Regulatory Expert, Regulatory Affairs, Novartis Sverige AB
Top tier customers:
