COMPLETE EXPERT EVALUATION ENSURES OUR SYSTEMS ARE COMPLIANT, EFFECTIVE AND ALIGNED WITH YOUR MANUFACTURING NEEDS

Ana is a Pharmacist by education with a MSc in Pharmaceutical Sciences from the University of Oporto in Portugal. Ana joined ADAMAS Consulting following 7+ years as a Regulatory Inspector at INFARMED, I.P., the Portuguese National Competent Authority for Medicinal and Healthcare Products.

During her 7 years with INFARMED, Ana was responsible for conducting regulatory inspections and audits of GMP systems within highly demanding environments, also extending to GDP, GLP and GVP. This experience allowed Ana to gain an in-depth understanding of the regulatory authorities’ expectations and a comprehensive knowledge of the EU and US GMP regulations. She’s also conducted GMP inspections to third party countries on EMA’s behalf.

Ana’s integrated vision of Pharmaceutical Quality Systems serves her well in collaborating with internal and external customers to balance compliance with practical, fit for use solutions. As a passionate student of industry, Ana is remarkably driven and committed to bringing value to both clients and their supply chain partners alike.

Alex holds his BSc in Pharmaceutical Chemistry and is an experienced Quality professional. Alex is UK based and joined ADAMAS with 15+ years of experience within the Pharmaceutical Industry. He speaks fluent English and Greek and is responsible for GMP audits in Europe and surrounding regions.

Since starting in Quality Control laboratories as an analytical chemist performing method development/validation, Alex has gained a broad knowledge base in areas such as process validation, product technology-transfer, EU regulatory variation requirements and equipment qualification.

Alex has held management level roles in Quality Assurance, ensuring product quality & regulatory compliance, as well as Senior Technical Manager positions responsible for CMO management, oversight and tech-transfer of pharmaceutical products. This experience equips him well in evaluating manufacturing systems for early phase products, as well as late phase and commercial products for EU and US markets.

Alex is an IRCA accredited Pharmaceutical and QMS Lead Auditor with over 100 audits performed globally. Alex has previous experience auditing in India, China, USA, Canada, South America, Japan, and Europe.