Leaders in regulatory excellence
Our regulatory specialists take active roles in shaping key industry bodies including the European and United States Pharmacopoeia, EXCiPACT™ and IPEC. They represent our dedicated Pharma Manufacturing sites and act as the link between the Pharma business, the regional manufacturing sites and regional sales teams. Extensive experience in the submission and progression of new monographs and teams experience in supporting the use of novel and innovative pharmaceutical products in customer formulations had a particular role to play in the recent success of our business.
Lonna Tucker
Global Director, Regulatory Affairs, Croda Pharma
Lonna Tucker, Global Director, Regulatory Affairs, works with numerous clients and products to provide support for regulatory filings at all phases of development, including commercialization. This includes drug master file authoring, editing, and coordination of information provided by subject matter experts. Drug Master Files are prepared and submitted in electronic Common Technical Document (eCTD) format. Submissions are supported primarily in the United States, Canada, and the European Union but submissions in other countries are also included. Interaction with Health Authorities and knowledge of global regulations are key components of Avanti’s regulatory department. Lonna has held Regulatory Affairs Certification (RAC, US) since 2011.
Miquel Mir
Global Quality and Regulatory Manager – Pharma excipients
Miquel has a PhD in organic chemistry and joined Croda (Uniquema) 20 years ago as the European Technical Service Manager for Pharma. Since then, he's worked in different positions on areas of quality and GMP’s, regulatory affairs and product development. He was a member of the Ph. Eur. Group of Experts 13H (fatty acids and derivatives) during the period 2004-2008. In his current position as Global Quality and Regulatory Manager - pharma excipients, he is working on assisting customers, global sales and site quality teams making excipients with respect to QA and RA matters. His work contributes to the development of the business for pharmaceutical excipients, human vaccines and consumer health by helping to meet the high expectations of the pharmaceutical industry on the quality and regulatory requirements of products.
Helen Albans
Regulatory Submissions Manager, Croda Pharma
Helen Albans is Regulatory Submissions Manager for Croda Pharma based in the UK. She has years of experience in product development, GMP manufacturing of Active Pharmaceutical Ingredients and Excipients, and regulatory affairs. Her extensive regulatory knowledge and experience includes authoring and submitting drug master files, regulatory lifecycle management, strategy for change implementation, and interacting with clients and Health Authorities.
Peter Bonde Jørgensen
Senior Regulatory Affairs Specialist
Peter is a Senior Regulatory Affairs Specialist with 12 years of experience at Croda, specializing in vaccine adjuvant products, including aseptically manufactured sterile products, particularly those produced in Denmark. Since 2018, Peter has been focused on Regulatory Affairs, supporting customers in obtaining vaccine approvals from health authorities worldwide, managing investigational products, and maintaining Drug Master Files (DMF). With a Master’s degree in Biology-Biotechnology from University of Copenhagen, Peter brings extensive expertise in regulatory compliance and navigating the complexities of the pharmaceutical industry.
Ella Chen
Product Safety Regulatory Affairs Manager - China
Ella Chen is the Product Safety Regulatory Affairs Manager in China. She is a regulatory affairs expert with years experience of regulatory affairs managing. She possesses an extensive knowledge on drug master files, toxicology, and chemical testing. As a member of IPEC China, she participated various discussions with authority on ChP development.
Globally connected
Quality
The pharmaceutical industry is highly regulated, and products of high and consistent quality are essential. When manufactured ingredients are used in drug or vaccines formulations, risk of quality failures must be minimised, and ultimately patient safety ensured.
EXCiPACT
Our leading global excipient manufacturing sites have completed the audit requirements of EXCiPACT and we are the first excipient manufacturer to achieve EXCiPACT certification across multiple production facilities.
Adjuvant GMP certificates
View and download the certificates from the two sites of Croda Denmark (Elsenbakken) and Smedetoften.