QUALITY ASSURANCE/COMPLIANCE

Our team has a long and broad experience within QA, in big global pharma companies as well as in small pharma companies, and vaccines, biologicals, medical device, cosmetics, food supplements and nutrition, Rx, OTC, generics, parallel import or distribution. We always work together to find flexible solutions and help you meet your deadlines, all hands on deck when required.

We can support you with all QA topics from junior to a very senior level such as:

• Batch release

• Complaint management

• Quality Strategies and projects

• QMS implementation and improvements (GMP/GDP/ISO13485)

• QP/RP full time or part time

• Audits - GMP/GDP/ ISO13485

• Audits - internal, supplier, joint audits, mock-audits

• Inspections - preparations before inspections from authorities.

• Risk assessments

• GAP-analysis and CAPA plans

• Life cycle management, e.g. change control, PQR/APR, complaints, deviations

• Due Diligence process

• Quality agreements

• Training programs, GMP/GDP/ ISO13485