We are a global 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.
Services provided:
Regulatory Affairs Services
We offer our regulatory expertise to companies in the various European and national regulatory procedures required to register medicinal products.
Quality Assurance Services
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.
Pharmacovigilance Services
We assist Marketing Authorisation Holders to fulfil Good Pharmacovigilance Practice Guidelines including critical processes and Pharmacovigilance System Master File.
Translations
We provide translation services for various languages such as: Maltese, French, Russian, Ukrainian, Belarusian, Kazakh and Moldovan