Our medical information services range from fulfilling physician requests to assisting you during the copy approval process. Our team delivers consistent, timely and accurate information based our client’s requirements. We also offer medical writing services. Our model is flexible and you can design it to suit your requirements.
We specialise in adverse event reporting for prescription drugs, devices and consumer products. All types of cases are processed by our team. We work on client specific projects including large data migration projects. Our team is committed to achieving your pharmacovigilance goals and meeting your deadlines.
We can work with you to design pharmacovigilance services based on your requirements. We will work with your operational procedures and workflows to integrate into your environment flawlessly. Communication and accountability are key factors and we take them both seriously.
Our regulatory experts will work with you throughout the product lifecycle.
We can work on a report in full entirety or a specific section. The following are the reports that we can work on as a comprehensive solution to your aggregate reporting needs.
- Periodic benefit/risk evaluation reports (PBRERs)
- Periodic safety update reports (PSURs)
- Developmental safety update reports (DSURs)
- Periodic adverse drug experience reports (PADERs)
- Support for risk management plans (RMPs) and risk evaluation and mitigation strategy (REMS)
Our goal is to help you reduce costs and increase efficiency while maintaining world class quality. Our highly skilled team can help you achieve all these challenges.