Due to increased demand for Pharma IT – Chemistry, Manufacturing and Controls (CMC) consultants we are expanding the department.
Our experienced Chemistry, Manufacturing and Controls (CMC) department now consists of Torben, Birthe and Maria – read more below the picture. Furthermore, we cooperate with a large number of freelance consultants.
Please contact Torben Elhauge if you want to know more or need support.
Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area. With an offspring in Analytical development, Torben has a broad experience within all parts of the CMC area from development over validation and registration to GMP release of products. Torben is experienced in working with Impurities, Stability, Specifications, Release of Investigation Medicinal, CRO’s and Tech Tranfer. Torben have assessed registration files at the Danish Medicines Agency and have written the analytical part of the registration file for several products. Torben holds a master’s degree in chemical engineering.
Experience with quality demands for active pharmaceutical ingredients and medicine products for the European market, according to The European Pharmacopoeia as well as to the ICH guidelines. Experience with quality demands according to EMA guidelines, quality demands for the documentation submitted to the Danish Medicines Agency for applications for variations to existing Marketing Authorisations as well as for applications regarding new Marketing Authorisations. Experience with development, optimisation and validation of analytical methods for implementation in European Pharmacopoeia monographs, assessment of the practical applicability as well as the documentation for analytical methods including the validation hereof, for active pharmaceutical ingredients and medicine products for the Danish Market. Experience with assessment of applications for variations to Marketing Authorisations for the Danish and European market.
Maria Høyer Engelhardt
Senior Pharma Consultant Maria Høyer Engelhardt holds more than 10 years of experience working in the pharmaceutical industry, working with quality, validation and processes, primarily within Quality Control. She has extensive experience within Quality Control, in particular with documentation, verification and validation of methods, set up and documentation of new processes, SOP writing and LEAN. Furthermore, she has good knowledge of QMS systems and the document structure. Experience with development and validation of microbiological methods and methods for raw materials.
Read more on the team and services here