Our Services help you maintain compliance with TGA requirements
We offer a whole spectrum of PV services, including but not limited to:
QPPV and Contact Person
Being a Qualified Person Responsible for Pharmacovigilance (QPPV) can be a daunting role for Sponsors. We have extensive experience in acting as QPPV and take the stress off the Sponsor as we understand the regulatory expectations.
Gap analysis
TGA’s requirements and expectations evolve like any other regulations. We stay on top of all relevant legislations and help sponsors to identify the gaps in processes and procedures, expand knowledge and increase confidence before audits and inspections.
ICSR case management
We have over 10 years of experience in end-to-end ICSR (Individual Case Study Report) processing to audit-ready standards. Our team also provides training in event coding, narrative writing and Safety Database utilisation to optimise safety evaluation and ongoing Risk-Benefit reviews.
PV System
We have built Pharmacovigilance (PV) Systems from the ground up as well as tremendously improved existing PV Systems, making them inspection and audit ready.
Literature Surveillance
We set up Global and Local literature management processes for our Clients and perform literature surveillance on an ongoing basis. We help with journal selection and set up the required search strings to pick up all hits relevant to the Client’s Product.
RMP and PSUR
We help our Clients with Risk Management Plan (RMP) and Periodic Safety Update Report (PSUR) writing to ensure all required information is included before the Health Authority submission and new information is evaluated properly before inclusion.
From clinical trials through to post-marketing monitoring, we ensure the patient is at the center of everything we do
Signal Management
We conduct signal detection and safety profiling activities for a wide spectrum of products: prescription, OTC, complementary and other therapeutic products.
PV Training
We offer comprehensive PV Training for all staff of Market Authorisation Holders and can tailor specific training courses for your internal teams, Partners and Vendors. We also offer in-depth specialised Pharmacovigilance courses for PV personnel.
Clinical Trials
We help CROs with their Pharmacovigilance obligations and reporting requirements as well as protocol and other clinical trial documentation review.
SOPs, WIs and SDEAs
We prepare all relevant Standard Operation Procedures (SOPs), Work Instructions (WIs), form and Safety Data Exchange Agreements (SDEAs) templates that you need to fulfil regulatory requirements.
ODCS and Patient Programs
We take care of Organised Data Collection Systems (ODCS) set-up activities, training, documentation and Vendor approval and qualification processes with the aim of minimising audit and inspection findings relating to ODCS.
Regulatory requests
We handle a wide range of regulatory requests associated with Medical Devices, Biologicals, Medicines, Vaccines, Cosmetics and Nutritional products and help with regulatory document submission.