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Home > Our Services > GxP Services

GxP Services

Confidence Beyond Compliance

Ensuring your internal systems, or those of your supplier or client meet the necessary requirements, is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards.

A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical organizations to assure products’ pharmaceutical quality and patients’ safety. A well designed and efficient quality system will serve as a safe and sound basis for your business. It documents and verifies your approach for high quality products towards health agencies.

We have a broad spectrum of competencies in GxP quality management as well as in adjoining regulatory areas. This approach allows us to manage interfaces even in complex situations and provide additional value especially for small- and medium-sized organizations.

We offer advice, guidance and solutions in the following areas:

  • Providing consultancy, gap analyses and operative support on GxP topics
  • Designing, implementing and optimizing your GxP quality system
    Preparing applications for manufacturing and wholesaling authorizations
  • Designing and documenting processes as SOPs
  • Implementing risk management approaches / FMEA analyses
  • Planning and performing GxP audits and self-inspections
    (incl. CAPA management)
  • Preparing and supporting health agency inspections
  • Supporting remediation activities

Related News

Is quality documentation an asset or a burden in regulatory affairs?
Is quality documentation an asset or a burden in regulatory affairs?
6th April 2022
Navigating the impact of the IVDR on marketed products
Navigating the impact of the IVDR on marketed products
24th March 2022
Minimizing risk during the transport of medicinal products
Minimizing risk during the transport of medicinal products
21st March 2022

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What our clients say

Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

Leading European Specialist Pharma Company
Head of Medical Writing and Publications

Highly competent, knowledgeable, absolutely reliable and dedicated to the projects

Europe based medium-sized biotech development company
Senior Director

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