Expert Services Across the Full Product Lifecycle

A successful product depends on three things: efficacy, safety, and profitability. That’s why early involvement of pharmacovigilance (PV) is essential. Many small biotech companies cannot afford a full-time PV team - but that doesn’t have to hold you back. Whether you need support for an existing team or a complete PV solution, we provide the expertise to keep your product safe, compliant, and on track for success.

We provide a comprehensive range of pharmacovigilance and medical information services designed to support pharmaceutical and biotech companies at every stage of their product lifecycle. From setting up compliant systems and managing safety operations to preparing for inspections and enabling early access programs, our solutions are tailored to ensure both regulatory compliance and patient safety.

Each service area addresses a specific need – whether it is building reliable infrastructure, fostering global partnerships, ensuring inspection readiness, managing day-to-day safety activities, or supporting innovative treatments through early access programs. By combining deep regulatory expertise with practical business insight, we help organizations achieve operational excellence while meeting the highest international standards.

System Implementation

System Implementation

Establishing and maintaining compliant pharmacovigilance and medical information systems.

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PV Alliance

PV Alliance

Where business development meets pharmacovigilance.

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Inspection Readiness

Inspection Readiness

Preparing for regulatory inspections and PV audits.

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Safety Operations

Safety Operations

Managing case processing, risk management, and reporting.

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Early Access Programs

Early Access Programs

Supporting the implementation of expanded access to treatments.

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