Quality Systems Development

We offer consultancy and regulatory services for the design, development, implementation and improvement of Quality Management Systems 

We are always aiming the same target: to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product. 

QMS Development

In the Pharmaceutical, Biotechnological and Cosmetic sectors, as well as in Medical Devices, food and others, it is of vital importance to implement and develop robust quality management systems that provide the necessary guarantees for the development, production and control of effective and safe products to the patients they are intended for. Continuous Improvement within the organization, throughout the product lifecycle, in permanent compliance with current regulations should be ensured.

Experts in Quality Systems Development

GxP Consultancy

Project Management

Project management for development/implantation of quality systems for new plants, processes and products.

GxP Consultancy


Advice on the definition or optimization of the structure of the quality unit and the distribution of responsibilities.

GxP Consultancy

Documentation Updates

Writing or updating quality system documentation: Policy, Quality Manual, Standard Operating Procedures (SOPs), etc.

GxP Consultancy

Technical Support

Support and technical assistance in quality areas (Batch Review, Deviation and Layer Management, etc.)

GxP Consultancy


Evaluation of regulatory and quality requirements applicable to each industry/process.

GxP Consultancy

Internal Audits

Quality System Internal Audits and Definition of the associated Action Plans.

GxP Consultancy

Risk Analysis

Systems and Processes Risk Analysis.

GxP Consultancy

GxP Compliance Preparation

GxP Compliance and Inspection Preparation

Solutions focused

Our commitment to our clients is to provide QMS solutions based on their custom requirements

We strive to provide technical knowledge and solutions adapted to the specific needs of each type of industry, client and associated process/product, considering the applicable regulatory requirements and national and international guidelines.

  • EU Regulations and Standards
  • Regulation US FDA 21 CFR
  • Guides ICH (Q8, Q9, Q10, Q11…)
  • GxP Regulation (GLP, GCP, GMP…)
  • Other International Regulations (China, UK…)
  • ISO 9001, ISO13485, ISO 22716

Where do you Need our Help?

For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

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Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
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  • Barcelona, Spain                               
  • +34 934 178065


  • Shanghai, China 


  • Hyderabad, India