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GxP Support: Advice & Implementation of Quality Systems

Constant changes in Quality System regulations and management in pharmaceutical companies and other related areas (e.g., manufacturers, MAHs, packaging material, distributors, food supplements, etc.) highlight the crucial importance of keeping quality systems updated and in line with current requirements.

Being essential to follow good practice guidelines to comply with regulators standards and ensure patients safety and high-quality pharmaceutical products, at Azierta, we develope, implement and maintain Quality Systems according to the needs of each company for enhanced resource management and results.

“We are experts in Quality Management with vast experience in the pharmaceutical industry”

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We provide comprehensive solutions in the following areas:
  • Evaluation, development, and implementation GxP quality system: GMP, GDP, GCP, GLP
  • Sterile manufacturing support EU GMP Annex 1 - CCS
  • Review, develop and implement QMS standard operating procedures (SOPs) ICH Q10
  • Data Integrity
  • GxP gap analysis
  • Validation Management
  • Quality Risk Management: ICH Q9 guideline
  • Planning and performance of High-quality GxP Audits
  • In-company training
  • Implant support

In addition, through GxP Compliance Adviser, we provide the most up to date GxP information to facilitate compliance with internal regulations. https://www.azierta.com/en/pharma/quality-systems/gmp-compliance-adviser

Azierta, provides highly specialized advice and technical support, with more than 10 years of experience, in compliance with Regulation (EU) 1907/2006 (REACH) as well as Regulation (EU) 1272/2008 (CLP) according to the corresponding guides published by ECHA.
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Just send us your questions & we will give you the help you need.