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

Optimisation

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

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.

REPHINE AUDIT GREEN GAP ANALYSIS ICON

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

REPHINE AUDIT GREEN AUDIT REPORT LIBRARY ICON

GMP Audit Services

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

REPHINE AUDIT BLUE INOVATION CONVOS ICON

GxP Consultancy

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

REPHINE DIGITALISATION PURP POST SUBM LIFECYCLE ICON

Digitalisation

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

Related Resources

SAP PALEX CSV Case Study Header Image (1500 x 844 px) Article

Change Management in CSV Projects: A GxP Guide

Every change to a validated system carries risk. Discover the core components, roles and best practices that keep Change Management in CSV projects controlled, compliant ...
Read More
ICH E6 Guide Header Image (1500 x 844 px) Case Study

From Cosmetics to OTC: Full FDA GMP Compliance Achieved in 12 Months

A global cosmetics manufacturer wanted to enter the OTC pharmaceutical market but had zero GMP experience. In 12 months, their Spanish production site achieved full ...
Read More
Close up of nurse holding and typing on tablet CSV

Data Integrity Remediation: A Practical Framework for Pharma

Turn data integrity findings into a sustainable, risk based remediation plan. A practical 7 phase framework for pharma labs.
Read More
csv blog header jan 25 Article

GDP Transport Validation: A Practical Guide for Pharmaceutical Companies

Transport validation is a regulatory requirement under EU GMP Annex 15, yet many pharmaceutical companies still struggle with route selection and risk assessment. This guide ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan CSV

Validation in the New Pharma Reality: Compliance, Digitalisation and AI Under Rising Regulatory Pressure

Watch our webinar with Rephine and ValGenesis on modern, inspection-ready validation: what EU GMP Annex 11 and ALCOA+ now expect, and where AI fits in ...
Read More
Ensuring Compliance and Data Integrity in Pharmacovigilan CSV

Building Inspection-Ready Validation for a Digital, AI-Enabled World

Now watching on-demand: Rephine and ValGenesis on modern, inspection-ready validation, where AI helps in GxP, and what EU GMP Annex 11 and ALCOA+ really expect.
Read More
SAP PALEX CSV Case Study Header Image (1500 x 844 px) Article

Digital Solution Selection in Regulated Environments: Beyond Software Features

Feature lists do not guarantee a successful digital transformation. Discover why a structured, business-led selection process is the real driver of compliance, adoption and long-term ...
Read More
QMS IMP Header image case study May 25 Article

Veterinary GMP in Europe: New Dedicated Framework & VICH GL60 Guide

The EU veterinary sector enters a new era on 16 July 2026. Dedicated GMP regulations replace EudraLex Volume 4 for veterinary products. Learn what changes ...
Read More
GSPR MedTech guide header image .png Article

MDR & IVDR Compliance: A Strategic Approach for MedTech

Regulatory compliance under MDR and IVDR has moved beyond documentation to become a strategic discipline that shapes every stage of a medical device's lifecycle. This ...
Read More

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.
Social: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us

Strengthen Your Assurance Journey

GMP Chapter 22 Adapting to Hybrid Documentation Standards