PHARMACOVIGILANCE
Pharmacovigilance
BioScien, Pharmacovigilance consulting is constantly warranted throughout the medicine’s life cycle, starting from the establishment of the development program, continuing through the Marketing Authorisation Application, and later during post marketing periodic reporting to regulatory authorities. Pharmacovigilance consulting firms around the world are ready to offer their services. When seeking for pharmacovigilance consulting, one should always keep in mind that BioScien has been successfully delivering safety services for over years which renders it one of the most prestigious and reliable pharmacovigilance consulting firms.
BioScien has a wealth of experience and expertise across many therapeutic areas and currently provides support to clients with products either authorised or under development within wide range of areas such as cancer treatments, infectious diseases, oncology and cardiovascular diseases. Pharmacovigilance services offered by BioScien consist of but are not limited to pharmacovigilance. The high quality of provided pharmacovigilance consulting services is primarily ensured by the expertise and knowledge of ex-regulators as well as PV and Medical Information (MI) professionals forming BioScien’s leadership team.
A significant amount of pharmacovigilance consulting is provided by our PV system (including all activities contributing to the detection, assessment, understanding and communication of safety information, as well as risk management), act as a single point of contact for regulatory authorities on a 24-hour basis, act as a contact for PV inspections, oversee the safety profile of the company’s marketed products and any emerging safety concerns. We ensure that all BioScien forum and are kept up-to-date with key changes to PV legislation and guidelines. They are always ready to identify the need for additional risk minimisation measures, approve proposed risk minimisation measures within and, support the Regulatory department throughout communication with the competent authorities regarding coordination of additional risk minimisation measures and the effectiveness assessment, where applicable. They will ensure that the risk minimisation measures are implemented and their effectiveness is evaluated appropriately.
The requirements vary from country to country and the majority of local authorities will require an already at the stage of Registration and submission or product approval, regardless of whether the product will be launched or not. In other cases, an only be required when the product is launched in that particular country. BioScien has setup and offers an extensive network covering. Together with them, BioScien monitors the local regulatory requirements, therefore we have a good understanding of the needs in each country.
Audits, Inspections and SOPs
Other aspects of pharmacovigilance consulting offered by BioScien regard audits and/or inspections, and preparation of SOPs. BioScien consultants and executives have many years of experience of conducting pharmacovigilance audits worldwide and develop programmes with client companies to ensure that all elements of their pharmacovigilance system are appropriately covered. The process of creating and reviewing SOPs is ongoing drafting, reviewing, approving, training, implementation and periodic review are all part of the overall process. They are audited and inspected as part of a pharmacovigilance system. Creating an SOP is not a matter of a generic template SOPs should be company and product specific. Our consultants have been writing compliant SOPs for many years for a diverse range of companies and medicinal products and processes. No matter what size and shape your company is, your SOPs are all controlled, comprehensive and specific:
Pharmacovigilance consulting services are also provided by experienced and capable Project Managers (PMs) with excellent communication skills and robust management and organisational skills who will act as the key contact point of their assigned clients. Through regular teleconferences and frequent interaction, we aim to establish good relationships with our clients. Full transparency will be achieved by monthly reports on the project status.