Larhammar Consulting AB Information

Larhammar Consulting provides regulatory and chemical-pharmaceutical advice for pharmaceutical and biotechnology companies, to meet the requirements of regulatory agencies. Examples of services · Regulatory support and/or management of regulatory work in drug development projects. · Advice on regulatory strategies. · Arrange for scientific meetings or regulatory advice with European Regulatory authorities. · Compilation, submission and follow-up of clinical trial applications, marketing authorisation applications and variations. · Review of documentation including gap analysis of the quality part of documentation (Module 3) in clinical trial and marketing authorisation applications. · Follow-up and interpretation of European and national regulations, directives and guidelines. · On site management of Regulatory Affairs units. · On site project management in pharmaceutical development of drugs. · Business development in Regulatory Affairs and pharmaceutical drug development. · Teaching- and investigational commissions in drug development and closely related business. Upon customer request I also interact with other experts and consultants. If I have no possibility to take on a commission I can propose other consultants.