Literature searches, QPPV, DSURs writing, Clinical Trial Consulting, inspections & audits
Pharmacovigilance consulting is imperative throughout the medicine’s life cycle, and very essential for pharmaceutical and biotech companies.
Almond Pharma is ready to offer our services, and we have been successfully delivering safety services for over 11 years with a wealth of experience and expertise across many therapeutic areas to clients with products either authorised or under development within wide range of areas such as respiratory diseases, infectious diseases, oncology and neurology diseases.
Almond consultancy service offered consists of but are not limited to pharmacovigilance consulting – e.g. aggregate report writing, literature search, benefit-risk analysis, European Economic Area (EEA) Qualified Persons for Pharmacovigilance (QPPV), local QPPV, Safety data exchange agreement (SDEA), Development of risk management plans (RMPs), Development of pharmacovigilance system master file (PSMF), Development of standard operating procedures (SOPs), post-marketing and Clinical trial case processing, validated safety databases, auditing services and regulatory reporting.
Almond Pharma maintains high quality pharmacovigilance consulting services by the expertise and knowledge of ex-regulators as well as PV and Medical Information (MI) professionals who have experience in the blue chip pharma companies.
At Almond Pharma, a significant amount of pharmacovigilance consulting is provided by EEA and local QPPVs. This is a legal requirement for all Marketing Authorisation Holder’s (MAH). Our in house QPPVs will establish and maintain the PV system, on a 24-hour basis act as a single point of contact for regulatory authorities, act as a contact for PV inspections, oversee the safety profile of the company’s marketed products and any emerging safety concerns.
We provide robust and up to date training programs for our in-house, ensuring that they are kept up to date with the EU PV legislation and guidelines.
QPPV’s are essential as they are trained to identify the need for additional risk minimisation measures, approve proposed risk minimisation measures within the RMP, and will ensure that the risk minimisation measures are implemented and their effectiveness is evaluated appropriately.
The provision of Local QPPVs, also known as National Persons Responsible for Pharmacovigilance (NPRPs) or local contact person, although varying from country to country, is mandatory by national law. The requirement of an NPRP can be as early at the stage of Registration Dossier submission or product approval, regardless of whether the product will be launched or not.
Clinical Trials Consulting
We provide consultation regarding clinical trials and products under development, with our in house medical doctors who are responsible for signalling, SAE medical review and review of development safety update reports (DSURs).
At Almond Pharma, our team can support the development of PV systems and prepare associated documentation for clients.
- Named patient / compassionate use program Annual Safety Reports
- Periodic Safety Update Reports (PSURs)
- Risk Management Plans (RMPs)
- Standard Operating Procedures (SOPs)
- Pharmacovigilance System Master Files (PSMFs)
- Development Safety Update Reports (DSURs)