We set the bar high

We are deeply experienced GMP compliance specialists. For more than twenty years, we have been proactively helping life sciences companies around the world with quality assurance consulting, professional supply-chain auditing solutions, and targeted regulatory assessments and compliance services.

The clear choice for GMP compliance

For GMP Auditing, Quality Assurance & Regulatory Compliance, we’re the partner of choice for all of the stakeholders we deal with. These include:

  • Our clients’ Qualified Persons, Quality Assurance and Regulatory Affairs teams;
  • Manufacturer auditees who give us access to their facilities for detailed inspections;
  • The highly-qualified and respected professionals we engage; and
  • The Regulators whose evolving standards we closely track and fulfil.

Only the best will do

As a trusted and highly experienced GMP professional service provider, we attract the best people in our field and we have highly qualified experts operating across all of our key markets – from Europe, the US and South America to Japan, China, South Korea, India and more – all well versed in the latest relevant standards.

Our clients routinely commend us for the calibre of our professionals, the quality of our reports, the reliable consistency of everything we do, the high level of customer service we provide, and the overall quality of what we deliver

Our Leadership Team

Adam Sherlock 

CEO

Mark Croghan 

CFO

Eduard Headshot 2

Eduard Cayon 

CSO (Chief Scientific Officer)

Chris Burman 

VP Commercial

Alasdair Leckie Headshot

Alasdair Leckie

VP Audit Services

Marian San Headshot

Marian San 

VP Consulting & 

GM Spain

Vera Wang Headshot

Vera Wang 

GM China

Mamta Chawla Headshot

Mamta Chawla 

GM India

Aina Selles Headshot 1

Aina Selles

Quality Director

Jose Vergara Headshot

José Vergara

Technical Director

Tabata Bortuni Headshot

Tábata Bortuni

Auditee Director

Laura Mallo Headshot

Laura Mallo

Audit Operations Director

Atia Bukhari Headshot 1

Atia Bukhari 

Marketing Director

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.

Browse Audit Library

GMP Audit Services

GxP Consultancy

GxP Consultancy

Global Audit Library

Global Audit Library

REPHINE PURPLE ACCENT POST SUBM LIFECYCLE ICON

Digitalisation

Related Resources

Copy of Gold standard auditing Blog header Blog

Defining the Gold Standard: what does this mean in auditing?

From repeatable rigour and experienced expertise, to highly ethical and transparent practices Alasdair Leckie, VP Audit Services, Rephine As in any other area of life …

Read More

Rephine announces exclusive partnership with Pharmaoffer, as the only GMP audit services provider on the online marketplace

Pharmaoffer, the ‘Amazon’ of API suppliers, will link its customers to Rephine’s vast library of live, off-the-shelf GMP audit reports of manufacturers around the world …

Read More
PR Symposium featured image 2 Article

Rephine unveils agenda for Rephine Virtual Symposium 2023

Live online event to be held on April 17th-18th 2023 and will feature deep domain expertise within the scope of Quality Assurance. Stevenage, Hertfordshire, 27th …

Read More
Article

ValGenesis & Rephine Partner to Deliver Digital End-to-End Compliance Solutions for Life Sciences Companies

The strategic alliance will offer global pharmaceutical companies a streamlined, software-based solution to enhance quality assurance across their global supply chains San Francisco, February 28, …

Read More
Blog

EC Proposal Amending MDR & IVDR Transitional Provisions (2023)

EUROPEAN COMMISSION PROPOSAL AMENDING MDR & IVDR TRANSITIONAL PROVISIONS (2023) On February 16 2023, the European Parliament finally voted on the EU Commission Proposal about …

Read More
SQA PR Article 1 Article

Rephine to sponsor forthcoming Global Quality Assurance Conference

Specialist GMP auditors will provide three speakers at the event, focusing on Good Manufacturing Practice, Quality Management Digitization, and GMP & Quality Data Integrity.   …

Read More
shutterstock 793279159 Blog

New EU GMP Annex 1 requirements: EMA says no deadline extension

An appeal to the European health authority for leeway on the August 2023 compliance date has been rejected, putting the onus back on drug manufacturers …

Read More
Article

Preparing to meet EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products

Summary EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. …

Read More
Article

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation

Pharma Manufacturing Transitions to Biotech and Personalized Therapies Drives Quality Process Innovation Article by  Dr. Eduard Cayón, Rephine Published by Pharmaceutical Outsourcing The past decade …

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                               
  •  











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

    Newsletter