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USA | India

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info@atvigilx.com

Medical Writing

Our Medical Writing services ensure the creation of high-quality regulatory documents for pharmacovigilance. We produce clear, accurate, and compliant documents such as PSURs, RMPs, and CSRs, facilitating smooth regulatory submissions and effective communication with authorities.
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We have decades of experience ensuring compliance with rigorous regulations and certifications in pharmacovigilance, aligning with industry benchmarks for all our medical writing services.

Clinical Study Reports

We specialize in the preparation of Clinical Study Reports (CSRs), a critical component of our medical writing services for pharmacovigilance. Our team of experienced medical writers produces comprehensive & compliant CSRs that detail the methodology, results, and conclusions of clinical trials.

We ensure that each report adheres to regulatory guidelines & standards, providing clear & accurate documentation that supports the safety & efficacy of your pharmaceutical products. Our CSRs are meticulously crafted to facilitate regulatory submissions, presenting complex clinical data in an understandable & concise manner.

Our dedication to quality ensures that each report not only meets regulatory requirements but also enhances the credibility of your clinical research, fostering trust and confidence in your pharmaceutical products.

 

Regulatory Submissions

Expertly prepare and submit regulatory documents, ensuring compliance and facilitating communication with authorities.

Identifying potential risks
Global regulatory compliance
Accurate submission compilation
Facilitated regulatory communication
Expert navigation of complex processes

01Aggregate Reports


Preparing Aggregate Reports is critical in pharmacovigilance, essential for monitoring the safety profile of pharmaceutical products.

02Protocol Review


Ensure robust Protocol Review for successful clinical trials in pharmacovigilance, vital for study integrity & regulatory compliance.

03Risk Management Reports

Craft Risk Management Reports to assess and mitigate risks, ensuring product safety and regulatory compliance in pharmacovigilance.

04Risk Management Plans ( RMP)

Developing Risk Management Plans (RMPs) is pivotal in pharmacovigilance to ensure product safety and regulatory compliance

05Periodic safety update report

Prepare PSURs to review safety data, ensuring regulatory compliance & informed decision-making in pharmacovigilance.

06Benefit risk evaluation report

Create thorough Benefit Risk Evaluation Reports to evaluate product safety & efficacy, pivotal for informed decision-making in pharmacovigilance.

07Patient safety summaries/Narratives

Prepare Patient Safety Summaries/Narratives to document & communicate individual case safety reports, ensuring clarity & compliance in pharmacovigilance processes.

08Summary product characteristics

Prepare Summary Product Characteristics (SPC) to outline drug properties, usage, and safety data, vital for pharmacovigilance compliance.

09Package Inserts

Package Inserts are crucial documents included with pharmaceutical products, providing essential information to healthcare professionals and patients.

Pharmacovigilance System Master File (PSMF) Writing

A Pharmacovigilance System Master File (PSMF) is a comprehensive document outlining an organization’s pharmacovigilance activities. It details procedures, responsibilities, & processes for monitoring the safety of medicinal products.

The PSMF ensures compliance with regulatory requirements and facilitates effective risk management. It serves as a reference for regulatory authorities, providing insight into the organization’s pharmacovigilance system.

Accurate records
Precise documentation maintained
Regular updates
Consistent system reviews
Regulatory Adherence
Adherence to legal standards
Pharmacovigilance System Master File Writing
"Empowering Safety Through Words: Expert

Medical Writing

or Your Pharmacovigilance Needs.

Trust Atvigilx for Compliance and Clarity."