PV & Regulatory Services

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Pharmacovigilance

Pharmacovigilance  

is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The main aim of PV is to ensure patient safety and to improve public health by identifying and evaluating potential risks associated with pharmaceuticals.

Services We Provide

We are a provider of pharmacovigilance, regulatory and quality & compliance consultancy, and operational services. We help innovative life sciences companies expedite the product development and commercialization journey, reducing time to market.

Adverse Event Reporting

Collection and management of adverse event reports from healthcare professionals, patients, and other stakeholders.

Signal Detection

Identifying new risks associated with pharmaceuticals through data analysis.

Risk Management

Developing and implementing strategies to minimize risks associated with drug use.

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Periodic Safety Update Reports (PSURs)

Regular reports submitted to regulatory authorities that summarize the safety profile of a drug.

Risk Evaluation

Continuous assessment of the balance between the benefits and risks of a drug.

Patient Safety Communication

Informing healthcare providers and the public about safety issues related to pharmaceuticals.7. Follow Up Question/ LSO Connection etc.

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Regulatory Services

Regulatory  

services involve ensuring that pharmaceutical products meet all regulatory requirements set by government authorities. Our services ensure that products are safe, effective, and of high quality before they reach the market and while they are on the market.

Services We Provide

We are a provider of pharmacovigilance, regulatory and quality & compliance consultancy, and operational services. We help innovative life sciences companies expedite the product development and commercialization journey, reducing time to market.

Regulatory Strategy DevelopmentRegulatory SubmissionComplianceLabeling and Advertising ComplianceRegulatory IntelligenceHealth Authority Interactions