Leaders in regulatory excellence

Miquel has a PhD in Organic Chemistry and joined Croda (Uniqema) 25 years ago as the European Technical Service Manager for Pharma. Since then, he has worked in different positions in the areas of Quality and GMP’s, Regulatory Affairs and Product Development. He is currently a member of the Ph. Eur. Expert Group 13H (fatty acids and derivatives) and of the USP Excipient Expert Volunteers Committee and an active member of several committees and task forces in IPEC Europe. In his current position he is working on assisting customers, the global sales force and manufacturing site quality teams regarding pharmaceutical excipient regulatory matters. His work contributes to the development of the business for pharmaceutical excipients by helping to meet the high expectations of the industry on the quality and regulatory requirements for excipients.

Peter has a Master’s degree in Biology-Biotechnology from the University of Copenhagen and more than 14 years of experience at Croda. He specialises in vaccine adjuvants, including aseptically manufactured sterile products and investigational products, and is regularly consulted as a subject matter expert across Croda’s global adjuvant portfolio. His role bridges R&D, manufacturing, Quality, Sales and external regulatory partners, bringing product and site knowledge into customer projects, regulatory documentation, submissions, change assessments and Drug Master File lifecycle management.

In this capacity, Peter provides regulatory direction on both development-stage and commercial vaccine adjuvants, helping align scientific, GMP and market expectations into clear, practical and submission-ready positions. His work contributes to the development of Croda’s vaccine adjuvant business by strengthening customer-facing regulatory support and ensuring consistent regulatory input across human and veterinary vaccine development.

Hui Xin serves as the Head of Regional Product Safety & Regulatory Affairs (Asia) and is based in Singapore. She brings extensive experience in regulatory affairs management, with a strong focus on ensuring compliance and product safety across diverse markets. In her current role, Hui Xin collaborates closely with regional sales teams and manufacturing site quality functions to provide expert guidance on pharmaceutical excipient regulatory requirements. She plays a key role in supporting regulatory strategy, addressing compliance challenges, and facilitating alignment with evolving regional and global standards. Her work is instrumental in enabling market access, maintaining product quality, and ensuring adherence to regulatory frameworks across Asia.