Quality & Compliance

Quality & Compliance Service

Do you need consultants for quality and compliance services? Aptio Group ensures that Commissioning, Qualification and Validation planning and execution in pharma and medical device projects runs smoothly.

In a manufacturing process both quality and compliance are crucial components.

So what is quality and complince? Quality is defined as products and services that deliver intended performance and is related to the standard of products being produced, while compliance is defined as meeting regulatory requirements. While quality assurance isn’t required by law, meeting regulatory requirements is mandatory.

At Aptio we know that putting in place quality assurance is very beneficial for a business. It reduces risks of missing any compliance obligations and improves how your business is run.

Our consultants for quality and compliance services and pharma related tasks are engineers trained to identify potential compliance issues so that your business are able to resolve them quickly. We make sure to provide your business with the most suitable and cost-efficient solution. 

Our disciplines within quality and compliance include:

      • Project quality management and quality risk management.
      • Preparation of qualification/validation plans
      • Preparation of protocols, reports and supplier handling and audits.

Our consultants offer Quality Assurance and Compliance related services that suits your organization. We make sure to:

      • Prepare, review and handle SOP’s, batch release documentation, change requests, deviations and CAPA’s.

In addition, we provide our clients with

      • Quality Management System preparation and implementation.
      • Audits and Gap Analyses
      • Inspection Readiness services.

If your company need a consultants for quality and compliance services in the pharfmaceutical industry, do not hesitate to get in contact with us. Click here to get in contact with us or fill out the form below and we will get back to you.

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About Aptio Group

Aptio Group Denmark ApS is an innovative Danish pharma and engineering consultancy within Life Science. We are dedicated to support and manage projects in all pharma areas in the Life Science Industry. At Aptio group, we provide highly qualified consulting and engineering services within Quality & Compliance, Engineering, Project Management, biotech and Medical Device services to the pharma industry. We employ specialized Life Science consultants working with the largest pharma, biotech and medical device companies in Denmark and EU.

Our office is placed in Hillerod, but our consultants are primarily working at customer facilities in Denmark and EU.