Pharmaconsulta is an independent consultancy firm based in Malta (EU) specialising in pharmaceutical regulatory affairs.
Besides offering consultancy services, we also offer contract manufacture, laboratory analysis and QP batch release through approved suppliers that are all GMP audited and certified. We provide specialist advice and assistance with particular emphasis on EU GMP/GDP/GLP guidelines. The services we offer include but are not limited to EU market penetration, local representation and distribution, contract Responsible/Qualified Person (RP)/(QP) provision, licensing support, dossier submission review, Patient Information Leaflet (PIL) and Summary of Product Characteristics (SPC) origination and printing, advertising review, pharmacovigilance, Standard Operating Procedures creation (SOP) warehousing and logistics, regulatory solutions and strategic planning.
The firm was set up to provide high quality regulatory assistance to clients involved in manufacture and distribution of medicinal products. Our company is composed of specialised pharmacists with vast work experience in EU GMP and GDP approved sites as well as numerous years of regulatory positions such as Responsible Person (RP) positions and Qualified Person Pharmacovigilance (QPPV).
Our clients include international pharmaceutical companies based inside and outside the EU (3rd Country) and well as local distributors that require regulatory and licensing support.