Good Clinical Practices and Pharmacoviligance

In the changing pharmaceutical industry, companies are constantly filing drug applications for new medicines and new markets for existing medicines

This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs).

Good Clinical Practice

Pharmaceutical Industry should ensure that the requirements of Good Clinical Practice (GCP) are met, as well as the correct management and statistical processing of the associated data

Once the medicine is in the market, it is necessary to have a Pharmacovigilance system to properly manage the adverse events detected, in order to effectively detect and evaluate all potential problems. The Pharmacovigilance system should have an adequate Quality Management System and organization, as well as well-established processes to ensure compliance with Good Pharmacovigilance Practices (GVP).

Clinical Trials

Good Clinical Practices and Pharmacovigilance

Rephine’s experience in GCP and GVP includes:

Implementation of Quality Systems in medical research departments, pharmacovigilance departments and CROs.
Internal audits and audits to CROs and Pharmacovigilance Managers worldwide
Audits of clinical trials and bioequivalence studies
Validation of software related to clinical data management, statistical calculations with clinical data and pharmacovigilance data management

This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs), often located in many different countries.

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

Case Study

GMP Consultancy for a New Cannabis Manufacturing Plant

A start up cannabis manufacturer partnered with Rephine to design a GMP compliant facility, implement a practical Quality Management System and prepare for EU GMP ...

Article

How an Internal Services Audit Can Maximise Your Regulatory Compliance

Internal services audits play a critical role in maintaining GMP compliance and driving continuous improvement. This article explores how structured gap assessments, internal audits and ...

GMP Raising the bar Blog series Header image May 25

Article

Effective QMS Management Post-Go-Live: Strategies for Governance, Releases, and Continuous Improvement

After QMS go live, compliance and performance depend on strong governance, structured release management and continuous improvement. Learn how to sustain control, adoption and long ...

Ensuring Compliance and Data Integrity in Pharmacovigilan

Case Study

GMP Consultancy for a New Manufacturing Plant

With only a small team and a highly automated process, this biotech company needed to achieve EU GMP compliance fast. This case study shows how ...

CSV

EU GMP Draft Updates Explained: Chapter 4, Annex 11 and the New Annex 22

This expert Q&A session explores the draft EU GMP updates to Chapter 4, the revised Annex 11 and the new Annex 22 on Artificial Intelligence. ...

ICH E6 Guide Header Image (1500 x 844 px)

Article

Why Quality Can No Longer Live in Silos

Discover why siloed quality management is no longer sustainable in life sciences. Learn how integrating audits, advisory services and digital quality systems supports continuous GxP ...

QMS IMP Header image Blog case study May 25

Article

Why Most QMS Implementations Fail to Deliver Long-Term Value

Implementing a QMS is more than deploying software. Learn why most QMS implementations fall short, and what successful life sciences teams do differently to achieve ...

Case Study

Driving Global QMS Harmonisation for a Pharmaceutical Company

This case study outlines how Rephine helped a global pharmaceutical group implement and validate a harmonised Quality Management System across more than seventy sites. It ...

Guide

How to Structure MDR Technical Documentation (Annex II & III). A Practical Compliance Guide

This white paper provides a practical guide to structuring MDR Technical Documentation under Annex II and Annex III. It explains how to organise evidence, maintain ...

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.

GMP Audit Services

GxP Consultancy

Good Clinical Practices and Pharmacoviligance

In the changing pharmaceutical industry, companies are constantly filing drug applications for new medicines and new markets for existing medicines