Raising the Bar in GxP Compliance: Expert Insights from Rephine

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At Rephine, we go beyond audit checklists. We are committed to helping pharmaceutical, biotech, and medical device companies anticipate regulatory expectations, strengthen their quality systems, and build lasting trust with health authorities and partners alike.

This article series brings together twelve concise, high-value insights covering the most critical areas of GxP compliance, GMP consulting, and third-party auditing. Written by our experts, each article addresses a real challenge our clients face—offering practical guidance, regulatory context, and proven solutions.

Topics include:

  • The evolution of Quality Management Maturity (QMM)
  • How to prepare for successful GxP inspections
  • Best practices in cleaning validationdata integrity, and supplier qualification
  • Navigating the revised Annex 1 for sterile manufacturing
  • Enabling GxP-compliant digital transformation of your QMS
  • And ensuring independence in third-party GMP audits by managing conflicts of interest

Our insights reflect not only technical expertise, but also Rephine’s core values: integrity, independence, client partnership, and a win-win approach to compliance and efficiency.

Whether you’re a Quality Director, QP, RA lead, or Operations Manager, these resources are designed to support your journey toward sustainable compliance, risk control, and operational maturity.

Explore our upcoming series of expert articles, with two new insights released each week.

Authored by Dr. Eduard Cayón, a respected thought leader and Chief Scientific Officer (CSO) at Rephine, these articles will provide you with practical guidance, regulatory context, and proven solutions to the most critical challenges in GxP compliance.

Discover how Rephine can elevate your organization through world-class GxP services, third-party audits, and digital quality transformation.

Stay tuned and join us on this journey to raise the bar in GxP compliance—together.

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Dr. Eduard Cayón

CSO (Chief Scientific Officer)

About the Author:

Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.

We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.

With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.

Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.

He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.

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