Pharmacovigilance
We offer a comprehensive range of Pharmacovigilance solutions spanning the entire product lifecycle—from clinical development through post-approval and post-marketing phases. Our services are designed to help our customers ensure patient safety, maintain regulatory compliance, and effectively manage benefit–risk profiles.
We support early-phase and late-phase clinical trials with robust safety monitoring, adverse event management, medical review, and safety reporting. Following market authorization, we provide continuous pharmacovigilance activities, including case processing, signal detection, risk management, periodic safety update reports (PSUR/PBRER), and regulatory submissions in accordance with international guidelines.
By combining scientific expertise, regulatory knowledge, and efficient safety systems, we help our customers meet global pharmacovigilance requirements while ensuring high-quality, compliant, and timely safety oversight.
What does Pharma Expert Solutions specialize in?
Pharma Expert Solutions specializes in regulatory affairs, quality assurance, and pharmacovigilance services. We support pharmaceutical, biotechnology, and medical device companies throughout the product lifecycle, from development to post-marketing compliance.
What types of companies do you work with?
We work with pharmaceutical, biotechnology, and medical device companies of all sizes, from emerging startups to established international organizations, helping them meet regulatory and compliance requirements worldwide.
How does Pharma Expert Solutions support regulatory compliance?
Our experts provide tailored regulatory strategies, dossier preparation, authority submissions, and ongoing compliance support to help clients navigate complex and evolving national and international regulations with confidence.
What pharmacovigilance services do you offer?
We offer a full range of pharmacovigilance services, including safety monitoring, case management, signal detection, risk management plans, and post-marketing surveillance to ensure patient safety and regulatory compliance.
What makes Pharma Expert Solutions different from other consulting firms?
Our strength lies in our 15+ years of experience, highly qualified expert team, personalized approach, and deep understanding of global regulatory environments. We focus on building long-term partnerships based on trust, quality, and results.
What is your mission as a company?
Our mission is to help healthcare industry stakeholders overcome complex regulatory challenges, ensure the safety and quality of their products, and maintain full compliance while supporting sustainable growth and innovation.
