Larhammar Consulting AB
Regulatory and pharmaceutical advice for pharmaceutical and biotechnology companies
With 25 years of experience in chemical-pharmaceutical and regulatory drug development I started Larhammar consulting.
· 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
· 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).