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

Article

Maintaining Data Integrity with Digital Validation

The importance of data integrity is a widely discussed issue. There has been a rise in regulatory bodies like the FDA and WHO auditors focusing ...

Blog

Shaping the Future of Femtech to Inspire Inclusion and Innovation

On International Women’s Day, it’s crucial to shed light on the ongoing gap in women’s health equity and the pressing need for further support.

Article

3PARL® Consortium grows stronger with Qualandre’s emphasis on ethical conduct and trustworthiness

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.

Unrecognizable lab worker inspecting blood sample under microsco

Blog

Innovative Solutions for Cancer Diagnosis and Prevention

As we navigate the complexities of cancer care, there’s a shared commitment to driving change and ensuring equitable access to life-saving treatments. This year’s World ...

Article

Owlpharma joins 3PARL® to propel mission for ethical GMP supply chains in Life Sciences

3PARL® consortium welcomes Owlpharma, embracing their enthusiastic commitment to shaping auditing excellence.

Scientist chemist researcher doctor analyzing dna sample using medical microscope

GxP Consultancy

Decoding the technological minefield – A tactical approach to maximising Life Sciences R&D Software implementations

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

Blog

All change for computer software assurance in Life Sciences

Newly published FDA guidance on Computer Software Assurance (CSA), together with the second edition of the GAMP 5 guide, have shifted the emphasis away from ...

Article

Pharma Audit among newest members of the recently launched initiative 3PARL®

3PARL® consortium welcomes Pharma Audit in its mission to assure consistent high standard of GMP supply chain audits in the life sciences industry Stevenage, ...

Blog

Navigating ICH E6 (R3) changes for GCP excellence with a digitalised QMS process

In the realm of clinical research, adhering to Good Clinical Practice (GCP) through the ICH E6 guidelines has become an essential part for global compliance. ...

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.