Third Party Audits

We are aware of the needs and expectations of pharmaceutical companies and of the auditing pressure their suppliers undergo. This led us to create a model that provides advantages to all parts delivering a high-end audit service.

The Audit Process

We look for the best audit organization, avoiding time and efforts dealing with all the stakeholders to schedule the audits according to the sponsors’ deadlines and according the auditees’ schedule.

Once the audit is contracted by the audit sponsors, we initiate our process, setting up the audit days – according the auditee schedule and sponsors’ deadlines. Once the audit is arranged, we look for the best qualified auditor team  a Qualified auditors to best address the audit.

We take care of the entire audit lifecycle: audit preparation, execution, reporting and CAPA follow-up to allow you crossing out the audits to your suppliers from your list.

Why Choose Rephine?

Confidentiality Audits Icon 1


All information handled is strictly kept under confidential terms, including NDA or CDAs, from sponsors participating in the audit to the auditee information delivered to the audit sponsors through the personalized reports.

Impartiality Audits Icon


Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.

No Conflict of Interest Audits Icon

No Conflict of Interest

EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.

Personalised reports Audits Icon

Personalised Reports

Each sponsor receive a complete report with the information related to the products of their interest and the inclusion of the revision of their specific requirements.

Global Coverage Audits Icon

Global Coverage

With local auditors all around the globe, we can perform and deliver audits to any country.

Audit Scope Audits Icon

Audit Scope

API, Medical Devices, Distributors, GCPs, Packaging, Excipients, Carrier and Software

Shared Audits

We take advantage of our great experience and look for the most convenient solution to offer you the best price.

audits share the cost v2


Where do you Need our Help?

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

We provide extensive GMP consulting and regulatory 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



Related Resources


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

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

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

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

The roaring 20s: what a time to be Life Sciences’ Quality backbone

Bringing rigour to global supply chains as the reinvention of medicine continues by: Dr. Eduard Cayon, VP Audit Services, Rephine New waves of innovation in …

Read More

Practical Steps to Compliance with EU GMP Annex 1

About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …

Read More

CPHI 2022 Golden Ticket

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, UK
+44 1763 853135

Barcelona, Spain                               +34 934 178065

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