Chemistry, Manufacturing and Controls (CMC)

Pharma IT offer Chemistry, Manufacturing and Controls (CMC) consulting services to support drug development and support of marketed products.

  • CMC project management
  • Formulation support and analytical development
  • Development of quality target product profiles (qTPP) and identification of critical quality attributes (CQA’s)
  • Scaling of manufacturing processes, (tech) transfer to and management of Contract Manufacturing Organisation (CMO)
  • Preparation of reports and documentation to support regulatory filings
  • Quality Assurance of the manufacturing process
  • Qualified Person services for release of finished and semi-finished products

If you need support don’t hesitate to contact us.

Meet the Chemistry, Manufacturing and Controls (CMC) team:

Senior Pharma Consultant
Birthe Moesgaard

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.

Mass Spectroscopy Coupled to Separation Techniques in Bioanalytical Chemistry, Regulatory Life Cycle Management, Transferring HPLC methods to UHPLC, NMR Techniques in Drug Research, Advanced HPLC Method Development, LC Troubleshooting, Validation of Analytical Methods, Course in Industrial Drug Development, Sample Preparation and Separation Techniques in Bio-Analytical Chemistry, Author of 16 peer reviewed scientific papers. Numerous presentations at OMCL (Official Medicines Control Laboratories) meetings in countries around Europe, and at Expert group meetings at EDQM (European Directory for the Quality of Medicines & HealthCare) in Strasbourg.
Senior Pharma Consultant
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.

Various cGMP courses , LEAN, Project Management
Director of Chemistry, Manufacuturing and Control (CMC)
Torben Elhauge

Holds more than 25 years’ experience from the Pharmaceutical industry within the CMC area.

Experience working with both active pharmaceutical ingredients and medicine products for the European and American market, according to guidelines, ICH guidelines and the Pharmacopoeias (EP, PB, DLS and USP).

Broad experience within validation of analytical methods according to ICH Q2 (R1) and verification of monographs. Have been a tutor both at Pharmacon and at the MIND education under the university, lecturing in QC and analytical validation.

Experience working with registration files for the European and the American market both writing sections of the file and as an assessor within the Danish Medicines agency. Have been a part of the planning and execution of an advisory committee meeting as a part of the FDA registration process.

Experience from small development companies working in project teams and from quality control in larger setups. Always under GMP. Have also functioned as leader of an analytical development laboratory for several years.

Experienced in working with, CRO’s and Tech Tranfer.

Have held inspections both as an analytical expert within the Danish medicines agency and as a company representative. Have also functioned as an auditor for internal and external audits.

Torben holds a master’s degree in chemical engineering.

GMP, Quyality guidelines, Quality systems, HPLC, Dissolution, Analytical validation, Analytical development, Inspections, Audit,