Atrekia Pharma provides specialized Quality Assurance services to the pharmaceutical, biotechnology, medical device, cosmetics and food supplement industries. We help companies establish, strengthen, and maintain robust quality systems, that meet regulatory expectations and support operational excellence.

SOPs Development / Maintenance

  • Development, Implementation, and Maintenance of the client’s Quality Management System (Policies/SOPs), in accordance with applicable contractual, legal, and regulatory requirements.
  • Maintenance of the Quality Management System may include:
    • the Review, Revision and Distribution of Quality Management System Documents,
    • new Contractual / Legal / Regulatory Requirements impact assessment on Quality Management System Documents.

Quality Audits Conduct

  • Internal Audit Scheduling, Conduct & Reporting,
  • Supplier Qualification. Maintenance of the Approved Suppliers List, and qualification of Suppliers with impact to GxP activities. Qualification can be performed through Audits, Written Questionnaires, Certifications Review, or other means, as per supplied product/service GxP impact and relevant regulatory requirements.

Quality Audits / Inspection Support

  • Audit / Inspection Readiness Training to involved client employees,
  • Physical or Remote Participation in Audits / Inspections towards the Client.

Training

  • Training of personnel to the requirements of the Quality Management System (SOPs) and/or to general requirements (GxP training).

Development / Review of Technical Quality Documentation

In accordance with current GxP, applicable contractual, legal, and regulatory requirements, and Quality Management System needs, to the extent required by the Client:

  • Process / Product Validation Protocols and Reports
  • Facility or Equipment Qualification Documentation (URS/IQ/OQ/PQ Protocols/Reports)
  • Risk Assessment Plan / Report
  • Contamination Control Strategy
  • Product Quality Review
  • Quality Technical Agreements
  • Product Quality Complaints
  • Deviations / Non-Conformances & CAPAs
  • Change Controls
  • Arrangement and Reporting of Management Review Meeting (MRM)

Quality governance and oversight

Additionally, the Company offers various services in relevance to the above, such as Regulatory Strategy, Product Registration, Product Labeling Review, Product Dossier GAP Assessment, Communication with Competent Authorities.