Pharmacovigilance Medical Writing
In the dynamic landscape of drug development, meticulous documentation plays a pivotal role in securing regulatory approvals. Regulatory medical writing, a specialized discipline, bridges scientific insights with compliance requirements. Celegence, a leading regulatory affairs consultant, assists pharmaceutical companies in creating robust, submission-ready documents.
Global Team of Medical Writing Specialists
Our global team of medical writing specialists possess extensive knowledge across various domains, including drug development, multiple therapeutic areas, and diverse product types. We create submission-ready pharmacovigilance documents such as Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER), Periodic Adverse Experience Reports (PAER), Semi-annual safety update reports (SSUR), and safety reports specific to individual country requirements.
Sonia Veluchamy, CEO of Celegence, emphasizes their commitment to delivering exceptional PV Writing Services:
“Our team of experts ensure that every document is meticulously crafted keeping pace with the continuously evolving regulations and guidelines of the regulatory landscape. Our focus on patient safety and regulatory excellence allows us to support our clients in meeting their pharmacovigilance obligations with confidence.”
Pharmacovigilance Medical Writing – Technical Expertise with Editorial Precision
The in-depth knowledge of Celegence writers understand the intricacies of pharmacovigilance, regulatory guidelines, and scientific content. We integrate technical expertise with editorial precision to produce high-quality reports. Whether for PBRERs, PSURs, or country-specific reports, our experts work closely with stakeholders, including clinical operations, data management, and safety teams to ensure drug safety and compliance.
Pharmacovigilance Medical Writing Service
Pharmacovigilance is a critical aspect of drug development and post-marketing surveillance. Celegence is a global leader in medical writing, and boasts a team of seasoned experts. Our expertise seamlessly blends regulatory, clinical, and scientific content, harmonizing it with technical precision, editorial finesse, and rigorous quality control.
Explore how Celegence can revolutionize your PV writing by contacting us at info@celegence.com or visit us online.
The checklist highlights all of the documentation that you will need in place for certification of your IVD device and will serve as a guide to help you achieve ongoing compliance. In conjunction with this checklist, we are also able to provide you with bespoke strategies to bring your business up to speed. We are currently working with businesses from the United States, India, and throughout Europe to ensure that they are ready for the deadline in May of 2022.
