Pharmacovigilance Regulatory Support

Patient safety and product efficacy are the two most crucial factors that undergo constant scrutiny even after market entry, and ensure the fortune of a pharma manufacturer’s sustainability in the market. Periodically, manufacturers are liable to report their product’s safety and efficacy levels to the health authorities. There is a need for a Pharmacovigilance expert. PV is no longer just a checkbox; it is a strategically driven function that identifies, evaluates, and prevents adverse events. It minimizes risks and accelerates product life cycle management, hence protecting brand reputation.

We at Vigilare ensure that compliant Pharmacovigilance procedures are integrated across the product life cycle. From signal detection to ICSR case processing, and aggregate report writing to submissions, our expert team focuses on managing global compliance. Our ultimate goal is to promote the safe and effective use of pharmaceutical products, and to ensure that patients receive the highest quality of care.

Vigilare’s Pharmacovigilance Regulatory Support

Clinical Data Management (CDM)

To support robust safety analysis and reporting, we collect and ensure the clinical data is clean, validated, and regulatory-compliant. Aligning with ICH-GCP and CDISC standards, we provide CDM services that span across CRF design & Preparation, Database Design & Setup, AE/ASE Reconciliation, Electronic Data Capture, Medical Coding (MeDRA & WHO DD), Data Entry & Integrity Check, Database Validation and Query Management, Database Cleaning, etc.

Medico Marketing Services

The first possible way to avoid any Adverse Event (AE) is to educate the end-user about the safe and effective usage of a drug or device. With a perfect amalgamation of medical accuracy and marketing clarity, we offer Medico Marketing Support through Continuous Medical Education (CME) programs, Market Surveys, and Key Opinion Leader (KOL) Communication Strategies, Creating Patient Education Material and Scientific Narratives.

Quality Assurance

We believe quality is the only reliable factor in healthcare that can build customer trust. To ensure it is in line with the highest health authority standards, and to prepare organizations for end-to-end compliance and inspection readiness, we provide GCP and GLP audits, Investigator Site Audits, Vendor Audits, SOP Management, and Quality Systems Training and Development.

Clinical Trials Support

We support pharmacovigilance (PV) activities across all phases of clinical trials right from collecting safety data to handling Serious Adverse Events (SAEs)/Adverse Events (AEs). Our experienced team at Vigilare ensures safety surveillance is seamless and leverages integrated systems for regulatory reporting with zero errors. Our expertise lies across studies of healthcare and modern medicine including Oncology, Cardiology, Dermatology, Nephrology, Neurology, Gastroenterology, Orthopedics, Gynecology, and more.

Authorized Agent Services

Apart from quality, time is crucial to ensure quick market access for a medicinal product or medical device. We, at Vigilare, act as your authorized local agent to expedite product approvals. We extend support from documentation to distribution and ensure timely submissions, ongoing compliance, and a seamless interface with local health authorities. We are proven to be an end-to-end US agent for one of the growing Pharmaceutical companies.

Facts to Focus

Cases Processed

0 K

North American Submissions

0 K

Signal Reports Delivered

0 +

Aggregate Reports

0 K

Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.

We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.

Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.

We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.

Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.