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

Related Resources

Guide

Why eQMS is Important? The Critical Role of eQMS in Modern Quality Management

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end

Guide

Understanding the UKCA Certification for Medical Devices

Navigating UKCA certification is essential for manufacturers seeking access to the Great Britain market. Understanding the regulatory landscape, transitional provisions, and compliance steps is key ...

Blog

Understanding Computer System Validation and Data Integrity Compliance

In today’s fast-evolving regulatory landscape, maintaining compliance with Computer System Validation (CSV) and Data Integrity standards is more critical than ever. Organisations across the pharmaceutical, ...

Ebook

Key Deadlines for Medical Device Manufacturers under MDR and IVDR

Discover everything you need to know about MDR and IVDR compliance timelines for 2025. This eBook provides actionable insights to help manufacturers stay compliant and ...

Guide

REMS Program Audits: Ensuring Safety and Compliance

Navigating the FDA’s Risk Evaluation and Mitigation Strategy (REMS) requirements can be challenging, but it is critical for ensuring medication safety and regulatory compliance.

Blog

Considerations for the Use of Artificial Intelligence in Regulatory Decision-Making for Drugs and Biological Products

In January 2025, the FDA issued a draft guidance to industry and stakeholders on the use of artificial intelligence (AI) to generate information or data ...

CSV

Streamlining Analytical Instrument Qualification & System Validation (AIQSV) Guide

The Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) is an essential resource for pharmaceutical laboratories striving to meet ...

CSV

GMP Design Review – A Comprehensive Guide to Ensuring Compliance from Concept to Completion

An early-stage design review ensures your facility meets GMP standards, minimises risks of cross-contamination, and optimises efficiency—setting your project up for success from the start.

Blog

Mock Inspections: How to Prepare for FDA Compliance in the OTC Market

Ensuring Success in FDA Inspections for OTC Products: The Role of Mock Inspections

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.

Email: [email protected]

Social:

REPHINE HQ

Stevenage, UK
+44 1763 853135

REPHINE BARCELONA S.L.U

Barcelona, Spain
+34 934 178065

REPHINE CHINA

Shanghai, China

REPHINE INDIA

Hyderabad, India

First Name

Last Name

Phone

Country

Company

Job Title

Interested In

Message

Marketing Opt In

Rephine respects your privacy. Choosing to check the box means that you agree to the Rephine Privacy Policy. You can unsubscribe at any time.