Andrew Corrieri

At Pharmaconsulta, my responsibilities as Managing Director and Regulatory Affairs Consultant are constantly on the increase where, through the knowledge and confidence accumulated by my team and me over our extensive years in this field, we are able to provide advice on all regulatory GxP (Good Manufacturing /Distribution/Laboratory Practice) matters, ensuring compliance with all the regulations as defined by the relevant regulatory bodies, such as the European Medicines Agency, and the laws pertaining to this highly regulated business sector.

The firm consists of contract responsible persons, laboratory analysts and qualified persons for manufacturing. It deals with manufacturers in and outside of the EU where we audit manufacturers to prepare their premises for EU inspection. Through the Malta Medicines Authority, we obtain GMP licenses, GMP certificates and certifications of pharmaceutical products. We also provide medicinal product batch release through our contracted batch release sites. Similarly, pharmaceutical wholesale dealers contract Pharmaconsulta for GDP services. From efficient supply chain planning, document creation, preparation of SOP’s, maintaining of records, store preparation and maintenance, to obtaining, maintaining and/or renewal of a wholesale dealers’ GDP license to sell pharmaceuticals as well as training of staff.

Our daily running duties also include the life cycle management of a number of medical products, food supplements, medical devices and their successful registration. We carry out EU QPPV services, LCPPV services covering local literature tracking and monthly reporting for a number of Marketing Authorisation Holders, as well as reviews of variation submission documents and DHPC distribution services for a number of customers.