Larhammar Consulting AB

 Regulatory and chemical-pharmaceutical advice for pharmaceutical and biotechnology companies

With 25 years of experience in chemical-pharmaceutical and regulatory drug development I started Larhammar consulting. 

 

Previous employments:

· Research assistant, Department of Pharmaceutical Biochemistry, Uppsala University, Sweden, 4 years.

·  Manager of the Biochemical Section,  Division of Pharmacy, Medical Products Agency, Uppsala, Sweden, 8 years.

· Competence Development and Quality Assurance Manager, Medical Products Agency, Uppsala, Sweden, 3 years.

· Documentation- and Project Manager, Analytical and Pharmaceutical  R&D, Astra Arcus, Södertälje, Sweden, 2 years.

· Regulatory Affairs Manager, Quintiles AB, Uppsala, Sweden, 1 year.

· Director of Regulatory Affairs, Quintiles AB, Uppsala, Sweden, 7 years

 

Previous assignment:

· Biochemical analyses and control of native and biotechnological peptides, proteins, blood products and allergen extracts.

· Development of chromatographic, electrophoretic and immunometric techniques.

· Review and assessment of the chemical and pharmaceutical documentation for clinical trials and marketing authorisation of native and recombinant peptides, proteins, blood products and allergen extracts. 

· Task force committee for development of an international standard of recombinant human growth hormone.

· Chemical and Pharmaceutical expert reports in CNS and Infection.

· Project management and compilation of quality documentation for CNS products  and monoclonal antibodies.

· Clinical trial applications to regulatory agencies.

· Applications for scientific meetings with regulatory agencies.

· Build-up of and Director of Quintiles’ Nordic Regulatory Affairs group.

· Business Development in Regulatory Affairs.

 

Collaborations with other experts and CROs (Contract Research Organisation).