Expert Guidance and Compliance in Pharmacovigilance System Documentation

Who We Are

CMPV Consultancy is a premier provider of pharmacovigilance services, specializing in the creation and maintenance of Pharmacovigilance System Master Files (PSMF). Our team of experienced pharmacovigilance professionals is committed to supporting pharmaceutical companies and CROs in achieving compliance with regulatory authorities worldwide.

Our Services

Our PSMF writing services are designed to ensure that your pharmacovigilance systems are thoroughly documented, up-to-date, and compliant with all regulatory requirements. Our services include:

• Custom PSMF Development: Crafting a comprehensive PSMF tailored to the specific needs of your pharmacovigilance system, ensuring it reflects the current structure, processes, and safety profile of your medicinal products.
• PSMF Maintenance and Updates: Regular updates to your PSMF to incorporate changes in the pharmacovigilance system and to ensure ongoing compliance with evolving regulatory requirements.
• Annex Creation and Management: Detailed development and management of PSMF annexes, including lists of important safety concerns, contractual agreements, and descriptions of computer systems used in pharmacovigilance.
• Audit Readiness: Ensuring your PSMF is always audit-ready by maintaining comprehensive, clear, and precise documentation that meets regulatory standards.
• Training and Support: Providing training for your team on the importance of PSMF and best practices for maintaining an effective and compliant pharmacovigilance system.

Why Choose Us?

• Expertise: Our team comprises pharmacovigilance experts with extensive regulatory knowledge and experience in PSMF writing.
• Compliance Focus: We prioritize compliance with current regulatory guidelines, including those set by the EMA, FDA, and other global authorities.
• Tailored Solutions: We understand that each client has unique needs, and we customize our PSMF services to align perfectly with your specific requirements.
• Efficiency and Reliability: We provide timely and accurate service, ensuring that your PSMF documentation supports your pharmacovigilance activities effectively and efficiently.
• Proactive Approach: We take proactive steps to ensure your documentation is always current and reflective of the latest pharmacovigilance practices and insights.

Our Commitment

CMPV Consultancy is dedicated to enhancing the quality and compliance of your pharmacovigilance operations. Our PSMF writing services are integral to establishing a robust pharmacovigilance system that not only meets but exceeds regulatory expectations.

Contact Us

Learn more about how our PSMF writing services can strengthen your pharmacovigilance strategy. Contact CMPV Consultancy today to schedule a consultation or to find out more about how we can support your compliance and pharmacovigilance goals.

Ph. No. +919337504500

Email: cmpvconsultancy@gmail.com

Partner with CMPV Consultancy for comprehensive and compliant PSMF writing services. Let us help you ensure your pharmacovigilance system is documented thoroughly and maintained impeccably.