QMS Advisory

Digitalise your Quality, Clinical, Pharmacovigiliance and Regulatory processes leveraging Cloud Platforms

Portrait of man in a white robe and a cap standing in production department of dairy factory with laptop

How our QMS experts are setting a president for high quality QMS processes

Upgrade from outdated paper-based or generic systems to modern, cloud based solutions

We are recognised for delivering the highest quality services and solutions, with total reliability, through always acting with integrity, transparency and honesty. Rephine offers a full range of services in strategy, consulting, implementation and post implementation that help customers hitting the Pharma 4.0 for a more personalised healthcare and better patient outcomes. Our approach is agnostic, allowing us to support any Quality Management System (QMS).

Our QMS Services

REPHINE PINK COMMITMENT INNOVATION ICON

Initial Strategies

As life science experts we have a powerful team to support business, technology and data management processes. Main activities: Consulting on process transformation, Products and vendors evaluation, Roadmap development, Preparation of business cases, Development of Phase 0 projects.

REPHINE PINK POST SUBM LIFECYCLE ICON

Platform Implementation

Deeply experienced GxP consultants will support your Quality, Clinical, Regulatory and pharmacovigilance software implementation and configuration after rigorous certification programs from vendors. Adopting Agile methodologies and broad expertise, we will speed up the Time to Value and reduce the risk of the project.

REPHINE PINK QUALITY TICK ICON

Validation

We have a validation team that helps the customer to validate the configured system according to their requirements and computer system validation policies, following the complete system lifecycle and reducing the time required for Go-Live.

REPHINE PINK STAFF CUSTOMERS ICON

Change Management and Training

A crucial process to maximise the success of your implementation. Successful and sustainable change can only be achieved when everyone is on board.

REPHINE PINK COMM PARTNERSHIPS ICON

Managed Services

Maximise the success of your platform and reduce your global IT costs through the implementation of new processes, configuring enhancement or rolling the processes out in new sites, divisions or business areas.

REPHINE QMS PINK REMEDIATION ICON

Post-Go Live

Release management is an important part of the post go-live support. Engage and trust our experts for a comprehensive adoption of the new features included in each release.

Benefits for our clients

Rephine Tick

Streamlining the operational workflows to maximise business efficiency for each customer

Rephine Tick

Increase visibility and control over regulated data across all GxPs areas

Rephine Tick

Reduce the total cost of ownership by adoption of cloud technologies in the quality and regulatory areas

Rephine Tick

GxP practitioners and business consultants implementing solutions for your business processes

Rephine Tick

Compliance with cGMP, 21CFR Part 11 and Annex 11 of EU GMP

Our QMS Partners

REPHINE PINK QUOTE TOP
REPHINE PINK QUOTE BOTTOM

Master your QMS
implementation

Discover how you can navigate your implementation journey with effective strategies by viewing our latest Gold Standard QMS Whitepaper

Related Resources

GMP Design Review Guide header image CSV

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

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
mock inspection blog header Blog

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

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.
Read More
GSPR MedTech guide header image CSV

Essential Guide to EU GSPR Compliance for Medical Devices

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Cloud systems maintenance guide header image CSV

Maintaining Cloud Systems – A Continuous Effort

Navigating the intricate landscape of implementing systems in Life Sciences Quality & R&D requires a strategic approach to the end-to-end
Read More
Close up of nurse holding and typing on tablet 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 ...
Read More
Doctor 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 ...
Read More
Femtech Header 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.
Read More
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 ...
Read More
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
Read More

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

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: Linkedin

REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us