“The expert in asepsis and sterility assurance“

Quality Systems

Quality Systems for Pharmaceutical Manufacturers

If you need world-class quality systems in place at your facility, Galenisys can help you design and implement robust quality systems that meet the latest US and EU standards.
Our pharmaceutical consultants are up to date with the latest FDA and EMA regulatory requirements and have extensive experience working with major manufacturers and regulatory authorities.
This helps us create and implement expert quality control and quality assurance procedures in your facility.

In three steps, we can:

  • Inspect your facility and conduct a full evaluation of your requirements
  • Create a set of objectives for your quality systems, and design a system that will meet them
  • Help you put in place the right high-level structure to oversee and ensure quality at every stage of the pharmaceutical manufacturing process.

We will then give you everything you need to meet inspection requirements and maintain your QC and QA systems to the highest standards, including:

Quality systems documentation

We will produce a complete set of documentation that is tailored to your company, your facility and your manufacturing process.
This documentation will show:

  • A detailed overview of your quality systems
  • How you have implemented your quality systems
  • Procedures for the ongoing management of your quality systems
  • How your quality systems are reviewed and approved.

Once you have approved the documentation, Galenisys will publish it under your company’s own branding, providing you with a professional document that’s easy to reference both for you and for regulatory inspectors.

Communication and training for QC and QA procedures

Galenisys consultants will help you ensure your quality systems operate effectively by producing a quality systems communication plan tailored to your company, as well as providing training for your staff.
The plan will offer communications guidance and procedural information for all levels within your company, enabling efficient communication between staff and managers.
Our training will also help your staff understand the needs and uses of the different components of your quality system, while experienced instructors will help your team learn the most efficient and effective ways to ensure quality for your pharmaceuticals.

Galenisys have an extensive library consisting of our 250 bespoke training modules. Consult us for your bespoke training needs.

Implementing and evaluating your quality systems

Once these elements have been approved, we will help you design and execute a plan to implement your quality system.
Then we’ll run a stress test to evaluate its effectiveness in compliance with FDA and EMA regulatory requirements – ensuring robust QC and QA systems are in place and helping your pharmaceuticals reach new markets.

For more information about this or any other aspect of quality systems, contact Galenisys today.

Galenisys 11, rue Notre Dame de
Nazareth 75003 Paris – France
+33 (0)1 45554414

Galenisys USA Inc. 4359, Ravinewood
Dr. Commerce Mi 48382 USA
(248) 676 0521