Meet our team
Executive Team
Bachelor of Science (Honours) in Pharmaceutical Science, Master of Pharmacy, Master of Science in Pharmacy
andrew@pharmaconsulta.com | +35679303202 |
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.
Regulatory and Quality Assurance Department
Michael Rossi
- Regulatory Consultant, Responsible Person
Bachelor of Science (honours) in Pharmaceutical Science, Master of Science in Pharmacy
michael@pharmaconsulta.com | +35679475343 |
Currently working as Senior Pharmacist at Pharmaconsulta Ltd, carrying out pharmacovigilance local contact person activities in monthly reporting and local literature screening, carrying out EU QPPV tasks for Market Authorisation Holders for medicinal products. My role also includes acting as Responsible Person (RP) for medicinal companies holding an EU GDP license for the trading of medicinal products for human use.
After months of training, I have audited plantation sites for the cultivation of cannabis plants destined to medicinal cannabis manufacturing sites, and upgraded their quality system to EU GACP and EU GMP compliance. Prior to this role, I was Head of Quality Control and Regulatory Affairs in a company manufacturing and trading food commodities, food additives and chemical ingredients for the food and beverage industry. I also acted as a consultant on EU and local Food Labelling laws.
I have recently assisted in the auditing of FSSC22000 and BRC compliant food establishments and factories. My career initiated as Managing Pharmacist in a community pharmacy for eight years and have accumulated many years of experience in the administration and management processes of a trading company.
Dr Ipek Gurhan
- Quality Assurance Specialist
Medical Doctor, AI Specialist in Life Science and Healthcare
ipek@pharmaconsulta.com | +35679048832 |
Dr. Ipek Gurhan, born in Turkey, is a distinguished medical doctor and innovator in the integration of artificial intelligence (AI) within the Life-Science and Healthcare sectors. She earned her medical degree from Akdeniz University, Turkey, a prestigious institution renowned for its pioneering medical achievements.Passionate about leveraging technology to advance healthcare, Ipek pursued further education in data science, earning a professional certificate from IBM. She also completed courses in entrepreneurship at MIT and AI applications in Life Sciences and Healthcare from the AI Business School in Switzerland based company.In her professional journey, Ipek has made significant contributions to both the pharmaceutical and AI industries. As a Regulatory Affairs Consultant and Quality Assurance expert at Pharmaconsulta Ltd. in Malta, she has played a crucial role in maintaining and enhancing quality systems for pharmaceutical firms. Her expertise extends to conducting audits and inspections, ensuring compliance with EU regulations.Driven by innovation, Ipek founded Vigil AI, a company revolutionizing due diligence in the pharmaceutical industry by automating quality management systems through AI. Her leadership and vision are transforming traditional processes, enhancing accuracy, and reducing errors.
Fluent in English and Turkish, Ipek excels in adaptable environments, upholding the highest ethical standards. Her commitment to discipline and problem-solving continues to propel her career, making her a notable figure in the intersection of medicine and technology.
Maya Camilleri Sacco
- Regulatory Affairs Associate
Bachelor of Science (honours) in pharmacology
maya@pharmaconsulta.com | +35679246311 |
Maya holds a Bachelor’s degree in Pharmacology from the University of Malta, graduating as part of the first cohort of this course in Malta. She is currently pursuing postgraduate research at the university with the goal of earning her doctorate. As a Regulatory Affairs Associate, Maya specialises in pharmacovigilance, ensuring compliance with regulatory standards and addressing all related matters to uphold drug safety and efficacy.
Dr Alessandro Pappalardo
- Qualified Person, Responsible Person
Specialist degree in Pharmacy, Phd in Molecular Medicine
alessandro@pharmaconsulta.com | +393498167717 |
Dr Alessandro Pappalardo is an experienced pharmaceutical quality professional with extensive experience in ensuring compliance in the pharmaceutical and healthcare sectors. He holds a Specialist Degree in Pharmacy from the University of Catania (2004-2011), where his thesis focused on the involvement of the opioid system in the central anti-allodynic effects of Substance P. His academic journey continued with a PhD in Molecular Medicine from the same institution (2012-2016), where he studied the role of GABAA receptors on pancreatic alpha cells and their involvement in the desensitisation of FFA in type II diabetes mellitus.Dr Alessandro Pappalardo’s professional career began as a QC Senior Analyst at Chemi Pharma Ltd in Malta (2017-2018), specialising in aseptically manufactured and terminally sterilised finished products. He then progressed to the role of Head of QC and Responsible Person for Dietary Supplement Production at Pharmex Enterprise Ltd. (2018-2019), where he oversaw solid, semi-solid and liquid dosage forms. From there, he served as Qualified Person and Pharmacist at Pharmadox Healthcare Ltd. (2019-2022) where he ensured compliance for various dosage forms.
Expanding his expertise, Dr Alessandro Pappalardo joined The Force CT GmbH in Germany (2022-2023) as a Qualified Person and Responsible Person, where he set up quality systems for clients, managed GDP and API releases and provided interim management for quality assurance. Most recently, he worked at Panaxia Operations (Malta) Ltd. (2023-2024) as a Qualified Person and Senior Quality Assurance Pharmacist, ensuring compliance with GMP requirements, managing customer and supplier complaints, and overseeing the control and management of cannabis material related to manufacturing.
Currently, Dr Alessandro Pappalardo is a Qualified Person, Responsible Person and Regulatory Affairs Advisor at Pharmaconsulta Ltd in Ta’Xbiex, Malta. In this role, he provides strategic guidance, conducts assays and provides regulatory advice.
Ingrid Ross
- Qualified Person, Responsible Person, Person responsible for quality
Zsanett Kalan -Regulatory Affairs advisor
Bachelor of Science (Honours) Chemistry
zsanett@pharmaconsulta.com | +35699198563 |
Zsanett Kalan is an accomplished Regulatory Affairs Advisor at Pharmaconsulta Ltd., bringing a wealth of experience in quality assurance and regulatory compliance. In her current role, she leverages her extensive background to ensure the adherence to pharmaceutical standards and regulatory requirements. Zsanett’s keen attention to detail and her ability to manage complex regulatory landscapes make her a vital asset to the team. As a Quality Assurance Consultant at ICP Ltd., she is instrumental in managing the company’s Standard Operating Procedures and health and safety tasks, as well as organizing employee training. Her responsibilities encompass managing audits, maintaining quality management systems (QMS) in line with ISO standards, and coordinating stability studies and reports, thereby contributing significantly to the company’s compliance and operational excellence. Prior to her current positions, Zsanett honed her expertise in various roles within the pharmaceutical industry. She gained extensive experience in the sterile pharmaceutical industry as a Compliance Officer, her main duties included maintaining an online QMS system, SMF, QM, and assisting in regulatory affairs tasks. Her tenure as a QA Specialist Trainee saw her adeptly handling customer samples, assisting in audits, and maintaining quality technical agreements. Additionally, Zsanett’s role as a QA and PV Specialist at a consultancy company involved auditing for pharmaceutical clients and managing GMP/GDP pharmaceutical documents, which further solidified her proficiency in quality assurance.Zsanett’s career also includes significant laboratory experience. Throughout her years in various laboratories she performed analytical tests on finished pharmaceutical products, adhering to GMP and GLP documentation standards. This varied experience across different facets of the healthcare and pharmaceutical industries highlights Zsanett’s versatility and comprehensive understanding of quality and regulatory requirements, making her a well-rounded professional dedicated to excellence in her field.
Rebecca Corrieri
- Responsible Person
Bachelor of Science (Honours) in Pharmaceutical Science, Master of Pharmacy
becky@pharmaconsulta.com | +35699276768 |
I hold a Master’s degree in Pharmacy, completed in 2014. My professional career began as a Medical Representative, where I spent four years building a solid foundation in the pharmaceutical industry. During this time, I worked closely with health care professionals and developed a better understanding of regulatory requirements related to product promotion, clinical trials and compliance with industry guidelines. This experience provided me with valuable insights into the regulatory landscape, including the complexities of marketing distribution, and compliance within the pharmaceutical sector.
In 2018, I transitioned into a community pharmacy role. My responsibilities included ensuring adherence to standards for medication dispensing, proper storage, and patient safety. This enhanced my understanding of pharmacovigilance, quality assurance and the regulatory processes essential for the safe and effective use of medicines.
Currently, I am focused on Regulatory Affairs, where I am using my clinical and commercial experience to manage compliance. I aim to support clients in ensuring their operations meet the high standards required for the manufacturing, storage and distribution of pharmaceutical products. My comprehensive background enables me to navigate the regulatory landscape with a balanced perspective on patient care, industry standards and regulatory requirements.
Finance Department
Maronia Saliba
- Finance Manager
maronia@pharmaconsulta.com | +35679999585 |
Maronia plays a pivotal role at Pharmacomsulta, overseeing accounting and human resources with exceptional precision and dedication. With a strong background in finance and people management, she ensures smooth financial operations and cultivates a positive workplace culture, strengthening Pharmacomsulta’s commitment to excellence and growth.