A Consultancy Service Provider based in Malta

Malta consultant service provider for pharmaceuticals and medical devices with focus to be loyal to patient health.

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.

 

Regulatory Affairs, Maltese Translations, Proof Reading, Product Information, Linguistic review, marketing authorisations, variations, renewals, withdrawal, regulatory intelligence, legislation scanning, medicines authority, inspections, capa, internal audits, training, local representative, change control, mah, marketing authorisation holder, Gap analysis, support, SOP, labelling, artwork, mock up.

Regulatory Affairs Services

We offer our regulatory expertise to companies in the various European and national regulatory procedures required to register medicinal products.

product quality complaints, service complaints, inspections, capa, quality management system, qms, quality assurance, quality control, Good distribution practice, gdp, internal audits, training, deviation, local representative, change control, temperature monitoring, mah, marketing authorisation holder, thermal validation, thermomapping, IT validation, Business Continuity Plan, BCP, Gap analysis, support, Malta, Standard operating procedures, SOP, Quality Manual, Quality Policy, Work Instruction, Controlled documents, medical devices, Medical Device Regulation, MDR, 2017/745, iso certification, iso 9001:2015, In vitro diagnostic, IVDR, 2017/746, Unique device identifier, udi, serialisation, 2d barcode, declaration of conformity, doc, CE mark, labelling, artwork, mock up.

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.

 

Product Information, marketing authorisations, variations, renewals, withdrawal, regulatory intelligence, legislation scanning, medicines authority, pharmacovigilance, EU QPPV, adverse event reporting, side effects, out of office hours contact, 24x7, medical enquiry, complaints, literature review, audits, inspections, capa, risk minimisation measures, quality management system, qms, quality risk management, qrm, direct healthcare professional communication, dhpc, periodic safety update report, psur, developmental update safety report, dsur, monthy reconciliation, quality assurance, quality control, Good vigilance practice, gvp, internal audits, training, deviation, local representative, change control, mah, marketing authorisation holder, IT validation, Business Continuity Plan, BCP, Gap analysis, support, Malta, Standard operating procedures, SOP, Quality Manual, Quality Policy, Work Instruction, Controlled documents, medical devices, Medical Device Regulation, MDR, 2017/745, iso certification, iso 9001:2015, In vitro diagnostic, IVDR, 2017/746, labelling, artwork, mock up.

Pharmacovigilance Services

We assist Marketing Authorisation Holders to fulfil Good Pharmacovigilance Practice Guidelines including critical processes and Pharmacovigilance System Master File.

medicines authority, pharmacovigilance, EU QPPV, adverse event reporting, side effects, out of office hours contact, 24x7, medical enquiry, complaints, literature review, audits, inspections, capa, risk minimisation measures, quality management system, qms, direct healthcare professional communication, dhpc, periodic safety update report, psur, developmental update safety report, dsur, monthy reconciliation, quality assurance, quality control, Good distribution practice, gdp, Good vigilance practice, gvp, internal audits, training, deviation, local representative, change control, temperature monitoring, mah, marketing authorisation holder, IT validation, Business Continuity Plan, BCP, Gap analysis, support, Malta, Standard operating procedures, SOP, Quality Manual, Quality Policy, Work Instruction, Controlled documents, medical devices, Medical Device Regulation, MDR, 2017/745, iso certification, iso 9001:2015, In vitro diagnostic, IVDR, 2017/746, Unique device identifier, udi, serialisation, 2d barcode, labelling, artwork, mock up

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.