Chemistry, Manufacturing & Controls Team

WE PREPARE HIGH QUALITY DOSSIERS ON ALL LEADING TOPICS, FROM THE SYNTHESIS OF DRUG SUBSTANCES TO PRODUCT DEVELOPMENT.

- Dr. Lutz Müller Head of Chemistry, Manufacturing and Controls/Chemist

Chemistry, Manufacturing & Controls Team

Dr. Lutz Müller is head of the CMC team and a qualified chemist. He began his professional career in drug substance manufacturing and now has over 20 years of experience in pharmaceutical development and regulatory. His team is dedicated to streamlining solutions to global pharmaceutical development, beginning with the early stages of an idea and continuing through to the scale-up, manufacturing, and analysis of both drug substance and product life cycles, offering advice along the value chain and achieving expedited time to market.

Lutz and his team also provide expertise on strategic planning, including supporting pre-clinical and clinical trial supplies, designing development programs, prepping dossiers of modules 2.3 and 3 for different regions (Europe, the US, CA, AU, and NZ), and producing drug master files, active substance master files, and applications for suitability certificates.

During the subsequent regulatory processes, his CMC team responds to authority concerns and regulatory authorities, conducts GMP and GCP audits, and aids in life cycle vendor selections and technology transfers. Additionally, Lutz and his team have extensive experience in herbal and chemically synthesized drug substances, as well as biological and biotechnological products.


Team Leader:

Dr. rer. nat. Lutz Müller

Head of Chemistry, Manufacturing and Controls/Chemist

Phone: +49 7632 8226-50
Fax: +49 7632 8226-555

Stephanie Atkinson

Senior Expert / MSc Organic Chemistry

Phone: +49 7632 8226-419
Fax: +49 7632 8226-22

Dirk Sorgenfrey, Ph. D.

Senior Expert / Pharmacist

Phone: +49 7632 8226-490
Fax: +49 7632 8226-22