Who we are

Anna brings more than 15 years of experience in global regulatory strategy, development, registration, and lifecycle management of medicinal products. Having held senior regulatory leadership positions within international pharmaceutical and biotechnology organisations, she has led complex regulatory programs spanning innovative and established products across multiple regions.

Her expertise includes regulatory strategy, Health Authority interactions, vaccines, biologics, global development programs, reliance pathways, regulatory end-to-end team management and cross-functional leadership. Anna is particularly passionate about helping organisations navigate complex regulatory decisions, align stakeholders, and transform regulatory challenges into practical development pathways.

Lucie is an experienced regulatory affairs professional with extensive expertise in European and international regulatory submissions, Health Authority interactions, and lifecycle management. Throughout her career, which started at the Czech Health authority and later moved to pharmaceutical industry, she has supported innovative products, vaccines, and established medicines across a broad range of regulatory procedures 
and markets.

Her strengths lie in regulatory strategy execution, coordination of complex submissions, Health Authority engagement, and cross-functional program management. Lucie combines strong technical expertise with a practical 
and collaborative approach, helping clients progress regulatory activities efficiently while maintaining focus on long-term objectives.

Barbora combines regulatory affairs expertise with strong project management and client relationship skills. She supports the planning, coordination, and execution of regulatory projects, helping clients navigate complex activities while maintaining focus on timelines, quality, and project objectives.

Through her structured and proactive approach, she helps transform regulatory strategies into practical and efficient execution. She is particularly valued for her reliability, attention to detail, and ability to keep complex projects moving forward.

Satpal specialises in Chemistry, Manufacturing and Controls (CMC), bringing many years of experience spanning analytical laboratories, quality functions, manufacturing environments, and regulatory affairs.

By combining scientific depth with practical insights of commercial manufacturing, he helps clients develop robust and sustainable CMC approaches throughout the product lifecycle, bringing strong CMC regulatory strategies and high-quality regulatory documentation. He is particularly valued for his ability to bridge technical and regulatory perspectives, helping clients address challenging CMC topics with confidence.

Anna specialises in regulatory submissions, and lifecycle management activities across multiple regions and regulatory procedures. Her experience includes regulatory documentation, submission management, labelling, and coordination of cross-functional regulatory projects.

Recognised for her reliability, organisation, and attention to detail, Anna helps transform regulatory strategies into efficient execution, supporting projects from planning through successful delivery.