Quality compliance and responsible person services:
Efficient handling solutions for quality compliance and responsible person obligations
Our team of trained and experienced consultants can help you manage your marketing compliance and support service operations for products marketed in Scandinavia.
Quality Compliance in the pharma industry has become increasingly resource demanding. For distribution companies with limited internal quality resources an experienced consultant can manage the RP function of the company and secure compliance and training.
We offer third party audits of your suppliers of GDP services. Audits may be carried out as stand-alone audits for your company or as joint audits with companies equal to yours.
For questions or requirements in regards to Quality Compliance and RP Services, please include a few details in the form.
Quality Compliance and Responsible Person (RP) services include:
Quality Management System (QMS)
Creation of new QMS for distributors
Alignment of corporate QMS to Danish, Swedish or Norwegian legislation
Planning and setup of annual quality cycle
Third party auditing
Conduct GDP audit on demand
Audit planning
Create joint audits
Good Distribution Practice (GDP)
Internal GDP training
Responsible person (RP)
Handling of WDA applications
Handling of authority inspections on behalf of the company
Perform and manage supplier qualification
Management of deviations, complaints and recall situations
Quality compliance and RP services adapted to your needs
PharmAdvice’s consultants have extensive experience with quality compliance and RP functions.
Contact us to learn how we can help you:
“We rely on PharmAdvice to help us stay compliant and to notify us early if any adjustments are needed. This helps us maintain our license to operate in key markets like Scandinavia and the EU – with additional support from their network of service providers. And we rely on PharmAdviceʼs medical consultant in matters of adverse events globally,ˮ says Kristian Uggerhøj.
Client: Kristian Uggerhøj, CEO, Alkalon A/S
Services: Pharmacovigilance, Regulatory Affairs
Collaboration: 2011-