Larhammar Consulting AB

Regulatory and chemical-pharmaceutical advice for pharmaceutical and biotechnology companies

Examples of services I provide

· 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.

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