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

Article

MDR & IVDR Compliance: A Strategic Approach for MedTech

Regulatory compliance under MDR and IVDR has moved beyond documentation to become a strategic discipline that shapes every stage of a medical device's lifecycle. This ...

Medical Device

MDR & IVDR Compliance as a Business Outcome

Rephine's 2026 White Paper on MDR & IVDR compliance: strategic guidance for MedTech companies to reduce regulatory risk, avoid delays, and reach the EU market ...

Case Study

Full GMP Internal Audit Program Executed On Time

A pharmaceutical manufacturer needed to complete their annual EU GMP internal audit cycle across 11 departments, without the internal capacity to do it. See how ...

Ensuring Compliance and Data Integrity in Pharmacovigilan

QMS

From local to global: scaling your QMS for UK–EU operations

Learn how UK life sciences companies can scale their quality management system into EU markets without losing compliance, visibility, or operational control.

QMS

Scale Your Quality System from UK to EU Without Losing Control

Learn how UK life sciences companies can scale their quality management system into EU markets without losing compliance, visibility, or operational control.

SAP PALEX CSV Case Study Header Image (1500 x 844 px)

Article

Pharmaceutical Equipment Qualification & Control System Validation

Qualifying process equipment and control systems is fundamental to GMP compliance. This guide breaks down how to define user requirements, apply risk-based testing, and maintain ...

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 ...

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