Quality & Compliance

Quality & Compliance in Pharma Manufacturing

We offer Quality Assurance and Compliance related services that suits your organization

Aptio Group has an experienced team of engineers, pharmacists and consultants ready to provide pharmaceutical and life science companies achieve and stay in compliance. Our team of skilled consultants has in-depth knowledgde and remains up-to-date on the latest legislation while meeting the  requirements set by regulatory authorities. They are trained to identify potential compliance issues so that your business are able to resolve them quickly.

We ensures that Commissioning, Qualification and Validation planning and execution in pharma and medical device projects runs smoothly. 


Quality Assurance and Quality Control Concept - Modern graphic interface showing certified standard process, product warranty and quality improvement technology for satisfaction of customer.

Our pharma experts provides service bridging all stages

We work closely with our clients to ensure that all quality related activities are carried out viably and effectively and in compliance with GMP. Our team are ready to support you in the following areas:

      • Quality Assurance (QA) of manufacturing activities, incl. Change Controls, preparation, reviewing and handling SOPs, Qualifications & Validations, CAPA and deviations.
      • Quality Assurance (QA)  in accordance with GMP regulations, quality agreements and Marketing Authorizations.
      • Quality Assurance (QA) of Facility & Equipment.
      • Quality Assurance (QA) of Qualification & Validation projects
      • QMS update and maintenance.
      • Analytical test results review and approval
      • Method validations and equipment qualifications.
      • Prepare and maintain specifications SOPs, batch release documentation, and other GMP documentation.
      • Internal/external audits and regulatory inspections.
      • Project Quality Management System preparation and implementation
      • Quality risk management
      • Audits and Gap Analyses
      • Internal/external audits and regulatory inspections.Inspection Readiness services.

Contact Aptio Group

Do you need assitance in any area of quality and compliance? We’ve got you! Whether it is short or long term, do not hesitate to get in contact with us. Our consultants provide high quality services tailored to pharmaceuntical industry.

Fill out the form and we will get back to you as soon as possible.

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