we are your quality guarantee

CONSULTANTS


Karina Elkjær

Owner of Elkjær Consult

Karina can help your company obtain results in Quality Assurance and Quality Control in the Pharmaceutical and Medical Devices industries. Karina has more than 20 years experience in the Pharmaceutical and Medical Device industries, 15 years Managerial experience in Quality Control and Quality Assurance. Karina has experience in audits and has been the responsible person for FDA; the Danish Medicines Agency and customer audits as well as internal and Supplier audits.

Karina can also use her experience in implementation and management of ISO 9001, ISO 13485, ISO 14644-6, ISO 31000, ISO 2859, GMP ICH Q7 and 21 CFR 820. This also inludes Quality Management Systems, complaints, non-conformities, Corrective and Preventative Actions, Calibration, Validation (including URS, FAT, SAT, DQ, IQ, Og and PQ).

Contact Karina via RAQA.

  • +45 4012 9969
  • laura@raqa.dk

Laura Rossing

Owner of RAQA

Laura can offer you assistance with technical documentation writing, procedures and help establish a Quality Management System, contract management etc. She has a extensive experience in Medical Devices, Health care and food production fields.

Laura is a generalist and is often used to trouble shoot and solve inter-company product related issues. Her main strengths are Regulatory Affairs and Quality Assurance Compliance, Procedure and technical documentation. 

Her aim is to help all sized companies with the Freelance or consultant tasks at hand for the time needed whether short term or long term, on-site or home-based.

Contact Laura on:

 

  • +45 4012 9969
  • laura@raqa.dk

local Expert in field

We help Local and International companies with specific Regulatory and/or Quality related tasks where you need expertise in-house and to comply with regulations or customer demands.

Laura Rossing

Owner of RAQA

Laura Rossing

Owner of RAQA

  • +45 4012 9969
  • laura@raqa.dk
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