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We are a team of former GMP/GDP inspectors eager to share our knowledge and pass our expertise in order to support the pharmaceutical industry.
We started this project in 2019 in order to connect with pharma players and provide first-class services that will help them fully comply with international Good Manufacturing Practice (GMP)/ Good Distribution Practice (GDP) regulations.
Crînguța Brăiescu
Crînguta has over 20 years of extensive experience in pharmaceutical activities, most of which was gained in her role as a GMP Inspector at the Romanian National Agency for Medicines and Medical Devices. Throughout her career, she has been involved in both national inspection programmes and international inspections of finished medicinal product and API manufacturers, conducted either within the national inspection framework or under EMA and EDQM inspection programmes.
For more than 15 years, acting as a single point of contact, Crînguta has developed significant expertise in the management of complaints, quality defects, and product recalls, as well as in the prevention and investigation of falsified medicines.
During her tenure within the Regulatory Authority, she acquired broad experience in drafting pharmaceutical legislation and a wide range of regulatory and guidance documents.
Crînguta also led the Quality Assurance department of a Romanian medicinal products manufacturer and served as a Qualified Person (QP) for import activities. She is currently engaged in GMP and GDP training, consultancy, and audit activities.
She has a thorough understanding of pharmaceutical manufacturing, quality systems, GDP and GMP requirements, and is committed to sharing this knowledge to support and enhance companies’ GMP compliance. Her professional approach is characterised by strong attention to detail and a genuine passion for people development, enabling her to deliver robust and effective training programmes.
Valeria Leca
Valeria is an experienced pharmacist with over 20 years of professional experience in the pharmaceutical sector. She began her career in medicinal product distribution, subsequently advancing to the Pharmaceutical Inspection Department of the Ministry of Health, and later joining the Pharmaceutical Inspection Department of the National Agency for Medicines and Medical Devices of Romania as a GMP/GDP Inspector.
Over a period of more than 10 years, Valeria conducted numerous GMP and GDP regulatory inspections both in Romania and internationally. During this time, she also contributed significantly to the development and implementation of the quality system within the inspectorate.
Drawing on her extensive regulatory background, Valeria is a highly skilled consultant and auditor, able to translate inspection experience into practical, risk-based guidance for pharmaceutical companies. In addition, she is an experienced speaker and trainer, delivering GMP and GDP training courses tailored to industry and regulatory needs.