Pharmacovigilance Consultancy Services

Pharmacovigilance consultancy services tailored to the
compliance and regulatory needs of MAHs and CROs.

Our Pharmacovigilance Consultancy Expertise

Services offered in a variety of ways that can be used to help MAHs, CROs, and pharmaceutical companies with all their PV requirements.

Global Pharmacovigilance Strategy and System Design

Consultancy services in pharmacovigilance provided by our consultants help in setting up an efficient pharmacovigilance system worldwide, which includes QPPV, case management, signal generation, and product lifecycle management.

Regulatory Compliance and GVP Alignment

We provide an assessment of your PV processes according to existing regulations and GVP modules, which will ensure that your organization is ready for inspections and complies with regulatory requirements.

Risk Management and Benefit–Risk Evaluation

Our consultants at DrugCard develop a customized risk management plan and risk minimization strategy, which involves evaluating the benefit-risk ratio.

Pharmacovigilance Process Optimization

We identify inefficiencies across your PV operations – from adverse events reporting and signal detection to ongoing monitoring and safety data analysis – delivering targeted improvements that strengthen your pharmacovigilance system.

How We Deliver PV Consultancy Services

Every engagement begins with a clear understanding of your organisation's PV needs, followed by structured delivery across four core phases.

Gap Analysis and Regulatory Risk Assessment

Our PV consultant team performs a comprehensive gap analysis for you, pointing out compliance issues and discrepancies between your existing practices and the regulations and guidance for GVP.

Tailored Advisory and Actionable Recommendations

Based on the results, we produce tangible recommendations adjusted according to the size, capacity, and strategy of your organization, making sure everything is feasible and complies with all the regulations.

Implementation Support and Stakeholder Alignment

DrugCard helps you throughout the process of implementation, working with both internal and external parties to embed any changes effectively into your entire pharmacovigilance process.

Ongoing Strategic and Operational Guidance

Apart from executing your solution, we can still assist you strategically and operationally in ensuring compliance during the entire procedure.

DrugCard Platform in Numbers

121+

Countries
Medical journals coverage

2200+

Local journals
Continuously monitored

Weeks
New country Easily Added

Key Benefits of Pharmacovigilance Consultancy

There is a lot of benefit that can be gained by working together with DrugCard, specifically your pharmacovigilance process and strategy.

Stronger Regulatory Compliance and Inspection Readiness

Through our experts, we can assure that your pharmacovigilance process complies with the GVP guidelines as well as regulatory requirements, enabling you to pass any future regulatory inspections.

Expert Support Across the Product Lifecycle

From clinical development and marketing authorisation through to post-marketing surveillance, DrugCard provides strategic PV consultancy services at every stage of your product lifecycle.

Clear, Scalable PV Processes

We help organisations design and optimise PV processes that are transparent, repeatable, and scalable – supporting efficient case processing, safety reporting, and ongoing monitoring as your portfolio grows.

Confident Decision-Making Based on Safety Data

DrugCard strengthens your ability to identify and manage safety signals, improving the quality of adverse events reporting, real-world data analysis, and development safety update reports across your products.

Who This Service Is For

The DrugCard pharmacovigilance consultancy solutions are developed with an eye towards serving marketing authorization holders, pharmaceutical firms, and clinical research organizations working within regulatory frameworks. Be it early-stage drug development, fulfilling post-market obligations, or getting ready for regulatory inspections, our consulting experts will be there to give you all the assistance you need.

DrugCard is Your Reliable Pharmacovigilance Consultancy Partner

Over five years of hands-on expertise in global pharmacovigilance and regulatory compliance
A dedicated team of qualified persons and experienced PV professionals
Customized services designed for your organization’s PV requirements
Rich industry experience in clinical, post-marketing, and inspection phases
Multiple engagement models as per your convenience

Start Your Engagement