Pharmacovigilance Services
Our Pharmacovigilance services ensure the safety and efficacy of your products throughout their lifecycle. We offer a comprehensive range of services to meet regulatory requirements and ensure patient well-being:
Literature Surveillance
Keeping a vigilant eye on the scientific literature to identify potential safety concerns and emerging trends.
Case Processing and Management
Thorough processing and management of adverse event cases to ensure timely reporting and follow-up.
Aggregate Reports Preparation
Crafting comprehensive aggregate reports, bridging reports, and annual safety reports in line with Health Authority Guidelines.
Risk Management Plans
Developing robust Risk Management Plans tailored to European and global regulatory standards.
Risk Evaluation and Mitigation Strategies
Strategizing and creating Risk Evaluation and Mitigation Strategies in accordance with FDA guidelines.
Signal Detection Services
Employing advanced techniques to detect and assess signals of potential risks.
Qualified Person for Pharmacovigilance (QPPV) Services
Providing QPPV services as per the latest regulations, ensuring compliance and oversight.
Call Center Services
Medical Information Call Center services to address dosage related queries and much more...
Medical Writing Services
Our Medical Writing services assist you in communicating your research and clinical findings effectively. We offer a range of writing services to support your scientific endeavors:
Research Proposals Preparation
Crafting compelling research proposals to secure funding and drive your projects forward.
Clinical trial protocols authoring along with informed consent documents and study reports
Authoring clear and concise clinical trial protocols alongside informed consent documents.
Clinical study reports preparation, synopses, safety and efficacy overviews and summaries
Preparing detailed clinical study reports, synopses, safety and efficacy overviews, and summaries.
Investigators′ Brochure development and updates
Developing and updating Investigators' Brochures to ensure comprehensive trial documentation.
Creating and updating of labels and leaflets
Creating and updating product labels and leaflets to reflect the latest safety and efficacy information.
Authoring of articles / manuscripts for scientific journals
Crafting well-structured articles and manuscripts for submission to reputable scientific journals.
Abstracts preparation, content development for posters and presentations at scientific conferences
Preparing impactful abstracts and content for posters and presentations at scientific conferences.
