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

Project Management

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

Optimisation

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

Documentation Updates

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

Technical Support

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

Evaluation

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

Internal Audits

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

Risk Analysis

Systems and Processes Risk Analysis.

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.

Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

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Case Study

New Solid dosage forms plant

The development of a project for a newpharmaceutical manufacturing plant with ourconsultants will allow you having a plant with anappropriate design to fulfill GMP requirements ...

Company News

Tim Hawkins Joins Rephine as CEO to Spearhead Global Leadership

Rephine, the experts in quality assurance (QA) and Good Manufacturing/Distribution Practice (GxP) compliance across pharmaceutical, biotech & medical device manufacturing supply chains, has announced the ...