We are a consultancy service provider for pharmaceuticals (human and veterinary) and medical devices. With over 13 years of experience working with diverse pharmaceutical companies and attending multiple audits, we offer our consultancy services in Pharmacovigilance (including EU QPPV services), Regulatory Affairs and Quality Assurance. We can also support your company during partner audits and authority inspections. You can find more detailed information in the dedicated sections of our website. You can contact us for more detailed information on how we can support you.
We offer our regulatory expertise to companies in the various European and national regulatory procedures required to register medicinal products.
We provide our expertise to support manufacturing sites and wholesale distributors in maintaining a GxP compliant Quality Management System in line with the relevant regulations and guidelines.
We assist Marketing Authorisation Holders to fulfil Good Pharmacovigilance Practice Guidelines including critical processes and Pharmacovigilance System Master File.
COVID-19 – Business Continuity (PV)
The current pandemic has strained human resources, overwhelmed by Pharmacovigilance obligations coupled with other GxP requirements. We can support in task prioritisation and relieve you of the extra burden.