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

Guide

Medical Device Software Testing for MDR/IVDR Compliance | Rephine Guide

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.

Case Study

Implementing a Site-Wide CPV Strategy to Strengthen Process Control

Discover how Rephine developed and implemented a site-wide CPV strategy to improve process control, ensure GMP compliance, and reduce manufacturing variability.

Blog

Continued Process Verification (CPV) in GMP Manufacturing

Discover how CPV ensures process control and GMP compliance. Learn key regulatory insights and explore a real case study from Rephine’s validation experts.

AI Act WP MedTech Header Image (1500 x 844 px)

Medical Device

The Artificial Intelligence Act (EU 2024/1689) Whitepaper: Key Obligations, Risks, and Compliance

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.

Guide

When Does Medical Software Qualify as a Medical Device? | MDR & IVDR Guide

Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.

Case Study

Navigating DMF Registration in China with Rephine

Explore case study showing the development of a project for a new pharmaceutical manufacturing plant with the objective to fulfill GMP requirements and minimise risks ...

Blog

Breaking into the Chinese Pharmaceutical Market: How to Successfully File a DMF

Learn how to navigate DMF submission in China with Rephine’s expert guidance. From compliance reviews to NMPA approval — streamline your entry into the Chinese ...

ICH E6 Guide Header Image (1500 x 844 px)

CSV

Understanding ICH E6 (R3): Good Clinical Practice and Computerised Systems Validation

The Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) is an essential resource for pharmaceutical laboratories striving to meet ...

Blog

AI Data Management & Governance: Best Practices for Compliance

In today’s fast-evolving regulatory landscape, maintaining compliance with Computer System Validation (CSV) and Data Integrity standards is more critical than ever. Organisations across the pharmaceutical, ...

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.