Zaklina is Director, Principal Consultant Innovative Therapies at PharmaLex. She is a regulatory specialist for Advanced Therapy Medicinal Products resp. Tissue, Cell and Gene Therapies with 12+ years experience in that field and 15+ years in the regulatory business. Before joining Pharmalex she worked for small biotech. Her main focus now is in regulatory strategy, program management and pharmaceutical quality. She and her team gained a lot of experience on very different types of ATMPs in different development phases.
She has also profound experience and knowledge with other innovative products such as biotech, blood, microbiota transplantation, herbals or complex purified components or combinations and gained also profound knowledge in Veterinary Medicinal Products and Medical Devices.
She is managing projects within interdisciplinary teams consulting biotech and pharma companies as well as clinics on topics such as development and early access, scientific advices, as well as preparation for central marketing authorisations.
She also has a profound network within pharmaceutical associations and regulatory authorities and is giving regular presentations and workshops.