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Quality assurance

Quality assurance

Quality systems and quality assurance activities are essential to all aspects of drug development and healthcare. LINK Medical offers the competence and know-how needed - from development to approval, from manufacturing to distribution.

We can be called upon for review of a single SOP or for setting up a complete quality system.

We have specialised professionals with broad experience from quality assurance, quality control and quality advisor positions with health authorities and the international pharmaceutical industry.

Our expertise can be called upon for review of a single SOP or for setting up a complete quality system. Our services can be used in-house or at the customer’s premises, with subcontractors, or we can take care of specific parts of a company’s processes. Let us advise you on the appropriate quality level of your operation.

Services within Quality assurance:

Audit services for:

  • Investigational sites
  • Clinical and analytical laboratories
  • Manufacturing, packaging and distribution
  • Phase I Units
  • Suppliers/Vendors
  • GCP, GLP and GDP compliance

Validation services for:

  • Computer Systems
  • Databases
  • Interim analysis

QA of study deliverables including:

  • Protocols
  • Case report forms (CRFs & eCRFs)
  • Clinical study reports
  • Statistical analysis plans (SAPs)
  • Tables and listings
  • Study files (at a site and in-house)

Other QA services:

  • Regulatory inspection readiness and response
  • Pre-audits and -inspections
  • Training to prepare investigational sites for regulatory inspections
  • Developing and implementing quality systems in small pharmaceutical, biotech and medical device companies






Updated

Related contacts:

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Randi Riise
Director Quality Assurance
Norway
Tel:+47 95 12 49 11
randi@linkmedical.no
280x180- Jan
Jan Hellqvist
Managing Director
Sweden 
Tel: +46 70 913 51 25
jan@linkmedical.se
marianne1- small HP
Marianne Holst
Managing Director
Denmark
Tel:+45 22 15 85 56
marianne@linkmedical.dk
6491smallweb
Uwe Anzenberger
Regulatory Country Manager
Germany
Tel:+49 176 8227 0156
      +49  30 2461 2025
uwe.anzenberger@linkmedical.de