PharmaVigil medical writing team has experience in providing support from early product development stages to consolidating clinical and other data, to producing various submission ready documents following our client’s or our own SOPs and applicable regulatory guidance.
We develop clinical study/BA-BE study protocols, clinical study reports, clinical patient safety narratives, investigator brochures, Informed consent forms, Clinical Overview (CO), Non-Clinical Overview (NCO), AtCO and other documents.
We support our clients with a complete set of Pharmacovigilance obligations compliance services. Whether that means helping clients establish their own global quality PV system, upgrading their existing systems or ensuring recurring activities.
PharmaVigil team prepares complete life-cycle of a regulatory dossier, supporting all the major steps in the preparation of a submission, liaison with the regulators for and on-behalf of our clients.
Our team is qualified and experienced in toxicological risk assessment, provide comprehensive services to meet your GMP needs and has helped products pass the rigorous regulatory scrutiny and reach the market.
Team is experienced in handling end to end case processing of spontaneous, literature and clinical trial origin cases using Argus, ARISg, PvNet, ABCube, BaseCon & Eudravigilance databases. System set up and implementation for Health Agencies like: US, EU, GCC India & CIS countries.
For those countries where we do not currently have our own office or company representation, we use our well-established network of qualified Partners associated with us for the common objectives. Each partner has underwent the qualification assessment with agreement on data confidentiality.
PharmaVigil delivers global solutions by empowering subject matter experts from across the world. Our network of offices and partners offer the global reach and local depth to navigate regulatory challenges around the world. As a group PharmaVigil is well versed with the applicable updated regulations.
We are committed to providing the best in customer services. We offer professional assistance to our customers for whatever they may require. We have satisfied national and international clients to whom we served for CTD dossier compilation and pharmacovigilance services. Name of those satisfied clients can be provided upon request bases.
The directives released by global regulatory authorities require each application for marketing authorisation to have a Pharmacovigilance System in place including the PSMF & qualified persons.
PharmaVigil is uniquely placed to support you in-